Special 510(k) Stretch: Indications-for-Use Changes in 428 Software Clearances

An analysis of 486 Special 510(k) clearances for software as a medical device from 1998 to 2026 found that 24 of the 428 clearances with comparable predicate indications text (5.6%) scored 5 or higher on a 0-10 AI-model panel, indicating a material expansion of indications for use, while 250 (58%) made no change and 118 (28%) made a trivial one. The share scoring 5 or higher rose from 3.4% before FDA's September 13, 2019 Special 510(k) guidance to 8.4% after it (Fisher's exact test, p = 0.03), and no clearance scored above 7. In three of the four largest changes, including Annalise Enterprise (K250831) and Stethophone Pro (K252595), the manufacturer already held the added indications under another of its own clearances.

A Special 510 k is a manufacturer's change to its own cleared device, with a 30-day review target. FDA's 2019 guidance https://fda.innolitics.com/guidance/special-510k-program?v=gfc09bf3b909-72dfe4d1f679a1bb states that certain changes to the indications for use may go through this pathway. This article measures how far the indications for use moved in every Special 510 k for software as a medical device SaMD in the FDA Device Explorer https://fda.innolitics.com/ . The cohort holds 486 clearances from 1998 to 2026. For 428 of them, the cited predicates have comparable indications text. A panel of AI models scored each change from 0 to 10 against the indications of the cited predicates. Of the 428 clearances, 250 58% make no change and 118 28% make a trivial one. Twenty-four 5.6% score 5 or higher, which means a material expansion on at least one dimension. No clearance scores above 7. In three of the four largest changes, the manufacturer already held the added indications under another of its own clearances. Annalise Enterprise <https://fda.innolitics.com/device/K250831?doc=summary&hl=11%3Awas%20previously%20acquired%20 K213941%2C%20K222268%20and%20K222179 &focus=1 combined the findings of three earlier Annalise clearances in one device. Stethophone Pro https://fda.innolitics.com/device/K252595?doc=summary&hl=4%3Aalso%20intended%20to%20be%20used%20by%20lay%20users&focus=1 added over-the-counter use by lay users, which an earlier Stethophone clearance already included. The share scoring 5 or higher is 3.4% before the 2019 guidance and 8.4% after it Fisher's exact test, p = 0.03 . The other material changes add anatomy, an imaging input or a function to a device whose claim type stays the same. FDA created the Special 510 k Program in 1998 for changes a manufacturer makes to its own legally marketed device. The program relies on the manufacturer's design controls. The submission presents verification and validation results in a summary or risk analysis format. FDA intends to process a Special 510 k within 30 days https://fda.innolitics.com/guidance/special-510k-program?v=gfc09bf3b909-72dfe4d1f679a1bb&hl=6%3Awithin%2030%20days%20of%20receipt%20by%20the%20Document%20Control%20Center&focus=1 of receipt. The statute gives FDA 90 days for a 510 k . The original program covered changes that left the intended use and the fundamental scientific technology unchanged. Under that policy, Special 510 k s with modified indications for use were routinely converted to Traditional 510 k s <https://fda.innolitics.com/guidance/special-510k-program?v=gfc09bf3b909-72dfe4d1f679a1bb&hl=6%3Aroutinely%20converted%20to%20Traditional%20510 k s&focus=1 . The September 13, 2019 guidance https://fda.innolitics.com/guidance/special-510k-program?v=gfc09bf3b909-72dfe4d1f679a1bb replaced that test. FDA now asks whether well-established methods are available to evaluate the change https://fda.innolitics.com/guidance/special-510k-program?v=gfc09bf3b909-72dfe4d1f679a1bb&hl=9%3Awell-established%20methods%20are%20available%20to%20evaluate%20the%20change&focus=1 and whether the results can be reviewed in a summary or risk analysis format. The guidance states that certain changes to the indications for use may be made https://fda.innolitics.com/guidance/special-510k-program?v=gfc09bf3b909-72dfe4d1f679a1bb&hl=7%3Acertain%20changes%20to%20the%20indications%20for%20use%20may%20be%20made&focus=1 under this approach. It also names changes to the indications for use that are supported by clinical, animal, or cadaver data https://fda.innolitics.com/guidance/special-510k-program?v=gfc09bf3b909-72dfe4d1f679a1bb&hl=14%3AChanges%20to%20the%20indications%20for%20use%20that%20are%20supported%20by%20clinical%2C%20animal&focus=1 as a scenario where a Special 510 k is not appropriate. The guidance includes a software example. A chest X-ray image processing program adds a feature that highlights lung nodules and changes its indications to describe nodule quantification. FDA's decision for that example https://fda.innolitics.com/guidance/special-510k-program?v=gfc09bf3b909-72dfe4d1f679a1bb&hl=19%3Ahighlights%20nodules%20in%20the%20lung&focus=1 is that the change cannot be reviewed in a Special 510 k , because no well-established method exists to evaluate it. My earlier article, How Far Can a 510 k Predicate Stretch? https://innolitics.com/articles/how-far-can-a-k-predicate-stretch/ , measured predicate distance across all AI/ML 510 k s. This article narrows the question to Special 510 k s for software and to one axis, the indications for use. The cohort is every record in the FDA Device Explorer with submission type Special and the software-as-a-medical-device flag, as of October 27, 2026. That gives 486 clearances decided between October 1998 and September 2026. The analysis resolves the predicate numbers cited in each 510 k summary and keeps the predicates whose indications for use are in the database. That leaves 434 clearances with at least one comparable predicate. In 99 of them, the indications text matches a cited predicate's text. Eighty-nine are identical apart from the device name, and ten differ by a few words. Each change is scored from 0 to 10 against the union of the cited predicates' indications. A feature counts as new only if no cited predicate already covers it. | Score | Meaning | |---|---| | 0 | Same indications, or wording-only edits such as trade names and model numbers | | 1 to 2 | Clarification or trivial addition, such as an accessory or a compatible component | | 3 to 4 | Minor expansion inside the same claim, such as a closely related sub-population or configuration | | 5 to 6 | Material expansion on one dimension, such as new anatomy, patient population, use environment, user, or input modality | | 7 to 8 | New clinical finding or condition, a new claim type, or material expansion on several dimensions | | 9 to 10 | A different clinical purpose from every predicate | Twelve AI models scored the 335 clearances whose indications text differs from every predicate. Five are general-purpose language models: Gemini 3.8 Flash, Claude Opus 5.5, GPT-6.1 Sol, Gemini 4 Argon and Kimi K3.1 Pro. Seven are decision models, which pick a level on the scoring scale and return a probability for each level: Liquid d1-ultra, Liquid d1.1, TypeSafe Jev 1.14, Perplexity Decider v1.2, Baseten Mammoth-1, Nace Drex Max and Morph Reflex. Each model scored every clearance independently. Each language model's ranking agreed with the other four at a rank correlation of 0.91 to 0.96, and each decision model agreed with the language models at 0.83 to 0.88. Some predicate clearances bundle several indications under one 510 k number, and the extracted indications field shows only one of them. The panel therefore re-scored the 98 clearances with a possible material change against the full text of each predicate's 510 k summary. The five language models and four of the decision models took part in this round. The reported score is the median of the five language models. The panel scored 25 clearances at 5 or higher. Each of the 25 then received three checks against the 510 k summaries. The first check compared every added phrase with the full text of the cited predicate's summary. The second check compared the predicate list in the Device Explorer with the predicates the summary names. The third check searched earlier clearances held by the same manufacturer for the added wording. The checks removed one clearance and corrected one predicate. syngo.via RT Image Suite https://fda.innolitics.com/device/K220783 left the list, because the full indications of its predicate already name every tool in the new indications. Visage PACS/CS 5.0 https://fda.innolitics.com/device/K072205 was re-scored against its own earlier version, which the summary names as a predicate, and it stayed in the list. The third check found three clearances whose added wording the manufacturer already held under another clearance. Those three stay in the list with a note. Twenty-four clearances remain. Every before and after excerpt in the table of the 24 matches the source indications text word for word. Six clearances are excluded because the predicate comparison is unsound. In four, the summary cites a K number that belongs to an unrelated device. For example, ACON On Call Diabetes Management Software https://fda.innolitics.com/device/K131469 cites K113566, which is a T-cell culture medium. In one, ARIA Radiation Oncology https://fda.innolitics.com/device/K093527 cites a spinal kit number in place of its Vision predicate. In one, the bundled predicate of BriefCase K221314 https://fda.innolitics.com/device/K221314 includes the large vessel occlusion indication on pages that the text extraction cuts off. The final analysis covers 428 clearances. | Change band | Clearances | Share | |---|---|---| | No change 0 | 250 | 58.4% | | Trivial 1 to 2 | 118 | 27.6% | | Minor 3 to 4 | 36 | 8.4% | | Material 5 to 6 | 22 | 5.1% | | New finding or several dimensions 7 to 8 | 2 | 0.5% | | Different clinical purpose 9 to 10 | 0 | 0% | Most SaMD Special 510 k s keep the indications for use of the predicate. The 99 matching texts and the 151 wording-only edits make up 58% of the cohort. Twenty-four clearances score 5 or higher, and none scores above 7. The table lists the 24 largest changes, ranked from the largest. Each row shows the predicate's indications next to the Special 510 k 's indications, as verbatim excerpts with omitted text marked by an ellipsis. Highlighted wording is what the Special 510 k replaced or removed blue and what it added orange . Each highlight links to its passage in the 510 k summary. Three rows note that the same manufacturer already held the added wording under another clearance. | | Device | Before: predicate indications | After: Special 510 k indications | |---|---|---|---| | 1 | Annalise Enterprise K250831 https://fda.innolitics.com/device/K250831?doc=summary&hl=7%3Avertebral%20compression%20fracture&focus=1 2025 Added wording already cleared to the same manufacturer under K213941 https://fda.innolitics.com/device/K213941 and K222268 https://fda.innolitics.com/device/K222268 | K222179 https://fda.innolitics.com/device/K222179 : chest X-ray cases with features suggestive of pleural effusion and pneumoperitoneum | features suggestive of the following findings: pleural effusion, pneumoperitoneum, pneumothorax, tension pneumothorax, vertebral compression fracture https://fda.innolitics.com/device/K250831?doc=summary&hl=7%3Avertebral%20compression%20fracture&focus=1 | | 2 | Stethophone Pro K252595 https://fda.innolitics.com/device/K252595?doc=summary&hl=4%3AStethophone%20Pro%20is%20also%20intended%20to%20be%20used%20by%20lay%20users&focus=1 2025 Added wording already cleared to the same manufacturer under K231551 https://fda.innolitics.com/device/K231551 | K240901 https://fda.innolitics.com/device/K240901?doc=summary&hl=4%3Aenvironments%20where%20health%20care%20is%20provided%20by%20clinicians&focus=1 : is for use in environments where health care is provided by clinicians https://fda.innolitics.com/device/K240901?doc=summary&hl=4%3Aenvironments%20where%20health%20care%20is%20provided%20by%20clinicians&focus=1 | can be used in clinical and nonclinical environments https://fda.innolitics.com/device/K252595?doc=summary&hl=4%3Acan%20be%20used%20in%20clinical%20and%20nonclinical%20environments&focus=1 … also intended to be used by lay users https://fda.innolitics.com/device/K252595?doc=summary&hl=4%3Aalso%20intended%20to%20be%20used%20by%20lay%20users&focus=1 | | 3 | AirStrip ONE Web Client with ACM K211949 https://fda.innolitics.com/device/K211949?doc=summary&hl=7%3Asuppressing%20non-critical%20alarms&focus=1 2021 | K160862 https://fda.innolitics.com/device/K160862 : To view the near real-time waveforms remotely … To provide a request for remote consultation | To view the near real-time and historic https://fda.innolitics.com/device/K211949?doc=summary&hl=7%3ATo%20view%20the%20near%20real-time%20and%20historic%20waveforms&focus=1 waveforms … To allow clinicians to manage secondary alarm transmission by suppressing non-critical alarms https://fda.innolitics.com/device/K211949?doc=summary&hl=7%3ATo%20allow%20clinicians%20to%20manage%20secondary%20alarm%20transmission%20by%20suppressing%20non-critical%20alarms&focus=1 | | 4 | syngo.via MI Workflows VB40A, Scenium K191309 https://fda.innolitics.com/device/K191309?doc=summary&hl=3%3AThe%20Scenium%20display%20and%20analysis%20software&focus=1 2019 Added wording already cleared to the same manufacturer under K173597 https://fda.innolitics.com/device/K173597 | K173897 https://fda.innolitics.com/device/K173897 : provide analytical tools to help the user assess, and document changes in morphological or functional activity | … The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans https://fda.innolitics.com/device/K191309?doc=summary&hl=3%3AThe%20Scenium%20display%20and%20analysis%20software%20has%20been%20developed%20to%20aid%20the%20Clinician%20in%20the%20assessment%20and%20quantification%20of%20pathologies%20taken%20from%20PET%20and%20SPECT%20scans&focus=1 | | 5 | ADAS 3D K210850 https://fda.innolitics.com/device/K210850?doc=summary&hl=3%3Aischemic%20or%20non-ischemic%20heart%20disease&focus=1 2021 | K191125 https://fda.innolitics.com/device/K191125?doc=summary&hl=3%3Anot%20intended%20to%20identify%20regions%20for%20catheter%20ablation&focus=1 : myocardial scar produced by ischemic heart disease … not intended to identify regions for catheter ablation https://fda.innolitics.com/device/K191125?doc=summary&hl=3%3Anot%20intended%20to%20identify%20regions%20for%20catheter%20ablation&focus=1 | myocardial scar produced by ischemic or non-ischemic https://fda.innolitics.com/device/K210850?doc=summary&hl=3%3Amyocardial%20scar%20produced%20by%20ischemic%20or%20non-ischemic%20heart%20disease&focus=1 heart disease … intended to be used for pre-planning and during electrophysiology procedures https://fda.innolitics.com/device/K210850?doc=summary&hl=3%3Aintended%20to%20be%20used%20for%20pre-planning%20and%20during%20electrophysiology%20procedures&focus=1 | | 6 | Glytec G+ System K101344 https://fda.innolitics.com/device/K101344?doc=summary&hl=2%3Ainfusion%20pump%2C%20and%20drive%20the%20blood%20glucose%20level&focus=1 2010 | K061110 https://fda.innolitics.com/device/K061110?doc=summary&hl=1%3Acalculate%20and%20recommend%20a%20dose%20of%20saline%2C%20glucose%2C%20and%20insulin&focus=1 : calculate and recommend a dose of saline, glucose, and insulin https://fda.innolitics.com/device/K061110?doc=summary&hl=1%3Acalculate%20and%20recommend%20a%20dose%20of%20saline%2C%20glucose%2C%20and%20insulin&focus=1 … not intended for use with patients with known insulin allergies or patients under the age of 18 https://fda.innolitics.com/device/K061110?doc=summary&hl=1%3Anot%20intended%20for%20use%20with%20patients%20with%20known%20insulin%20allergies%20or%20patients%20under%20the%20age%20of%2018&focus=1 | regulate the infusion of I.V. fluids, through an I.V. infusion pump https://fda.innolitics.com/device/K101344?doc=summary&hl=2%3Ainfusion%20pump%2C%20and%20drive%20the%20blood%20glucose%20level&focus=1 , and drive the blood glucose level towards a predetermined target range | | 7 | AI4CMR v2.0 K252084 https://fda.innolitics.com/device/K252084?doc=summary&hl=4%3Acalculating%20flow%20measurements%20of%20vascular%20structures&focus=1 2026 | K220624 https://fda.innolitics.com/device/K220624 : report cardiac function measurements ventricle volumes, ejection fraction, indices etc. | report cardiac function measurements … AI4CMR also supports clinical diagnostics by calculating flow measurements of vascular structures in 2D phase-encoded cardiac MR images https://fda.innolitics.com/device/K252084?doc=summary&hl=7%3AAI4CMR%20also%20supports%20clinical%20diagnostics%20by%20calculating%20flow%20measurements%20of%20vascular%20structures%20in%202D%20phase-encoded%20cardiac%20MR%20images&focus=1 | | 8 | Imbio PHA K241847 https://fda.innolitics.com/device/K241847 2024 | K203256 https://fda.innolitics.com/device/K203256 : maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements | maximal diameters of the right and left ventricles of the heart, the main pulmonary artery, and the ascending aorta https://highlight.innolitics.com/v/9xsSkjtSnFsj h=1 … report the RV/LV and Pa/Ao https://highlight.innolitics.com/v/9xsSkjtSnFsj h=2 ratios | | 9 | Axial3D Cloud Segmentation Service K231607 https://fda.innolitics.com/device/K231607?doc=summary&hl=5%3Apediatrics%20between%20the%20ages%20of%2012%20and%2021&focus=1 2024 | K221511 https://fda.innolitics.com/device/K221511 : diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications | cardiovascular applications in adults … may also be used for pediatrics between the ages of 12 and 21 years of age in cardiovascular applications https://fda.innolitics.com/device/K231607?doc=summary&hl=5%3Amay%20also%20be%20used%20for%20pediatrics%20between%20the%20ages%20of%2012%20and%2021%20years%20of%20age%20in%20cardiovascular%20applications&focus=1 | | 10 | VisAble.IO https://fda.innolitics.com/device/K240773 K240773 <https://fda.innolitics.com/device/K240773?doc=summary&hl=3%3AComputed%20Tomography%20 CT %20and%20Magnetic%20Resonance%20 MR %20image%20processing&focus=1 2024 | K223639 https://fda.innolitics.com/device/K223639 : Computed Tomography CT image processing software package … imports images from CT scanners | Computed Tomography CT and Magnetic Resonance MR <https://fda.innolitics.com/device/K240773?doc=summary&hl=3%3AComputed%20Tomography%20 CT %20and%20Magnetic%20Resonance%20 MR %20image%20processing%20software%20package&focus=1 image processing software package … imports images from CT and MR https://fda.innolitics.com/device/K240773?doc=summary&hl=3%3Aimports%20images%20from%20CT%20and%20MR%20scanners&focus=1 scanners | | 11 | True 3D Viewer K170167 https://fda.innolitics.com/device/K170167?doc=summary&hl=5%3ACT%2C%20MRI%20and%20Ultrasound%20sources&focus=1 2017 | K142107 https://fda.innolitics.com/device/K142107 : digital images acquired from CT or MR imaging devices | digital images acquired from CT, MRI and Ultrasound https://fda.innolitics.com/device/K170167?doc=summary&hl=5%3Adigital%20images%20acquired%20from%20CT%2C%20MRI%20and%20Ultrasound%20sources&focus=1 sources | | 12 | Exo AI Platform 2.2 K260217 https://fda.innolitics.com/device/K260217?doc=summary&hl=7%3Aechocardiography%2C%20abdominal%2C%20and%20lung%20ultrasound%20scans&focus=1 2026 | K240953 https://fda.innolitics.com/device/K240953 : trained and qualified to conduct echocardiography and lung ultrasound scans | trained and qualified to conduct echocardiography, abdominal https://fda.innolitics.com/device/K260217?doc=summary&hl=7%3Atrained%20and%20qualified%20to%20conduct%20echocardiography%2C%20abdominal%2C%20and%20lung%20ultrasound%20scans&focus=1 , and lung ultrasound scans | | 13 | ImagenSPECT 3.0 K201933 <https://fda.innolitics.com/device/K201933?doc=summary&hl=3%3Amultigated%20acquisition%20blood%20pool%20scans%20 MUGA &focus=1 2020 | K152503 https://fda.innolitics.com/device/K152503 : analysis and display of cardiac SPECT images | analysis and display of cardiac SPECT and planar https://fda.innolitics.com/device/K201933?doc=summary&hl=3%3Aanalysis%20and%20display%20of%20cardiac%20SPECT%20and%20planar%20images&focus=1 images … quantitation of multigated acquisition blood pool scans MUGA <https://fda.innolitics.com/device/K201933?doc=summary&hl=3%3Aquantitation%20of%20multigated%20acquisition%20blood%20pool%20scans%20 MUGA &focus=1 … early and late 99mTc pyrophosphate images https://fda.innolitics.com/device/K201933?doc=summary&hl=3%3Aearly%20and%20late%2099mTc%20pyrophosphate%20images&focus=1 | | 14 | densitas densityai K192973 https://fda.innolitics.com/device/K192973?doc=summary&hl=3%3Adigital%20breast%20tomosynthesis&focus=1 2020 | K170540 https://fda.innolitics.com/device/K170540 : compatible full field digital mammography systems | compatible full field digital mammography and digital breast tomosynthesis https://fda.innolitics.com/device/K192973?doc=summary&hl=3%3Acompatible%20full%20field%20digital%20mammography%20and%20digital%20breast%20tomosynthesis%20systems&focus=1 systems | | 15 | MI View&GO K201202 https://fda.innolitics.com/device/K201202?doc=summary&hl=3%3Aaid%20in%20radiotherapy%20treatment%20planning&focus=1 2020 | K191309 https://fda.innolitics.com/device/K191309 : support the interpretation of examinations and follow up documentation of findings | The images and results produced by MI View&GO can also be used by the physician to aid in radiotherapy treatment planning https://fda.innolitics.com/device/K201202?doc=summary&hl=3%3AThe%20images%20and%20results%20produced%20by%20MI%20View%26GO%20can%20also%20be%20used%20by%20the%20physician%20to%20aid%20in%20radiotherapy%20treatment%20planning&focus=1 | | 16 | EFAI RTSuite CT HCAP-Segmentation K231928 https://fda.innolitics.com/device/K231928?doc=summary&hl=3%3Aproviding%20initial%20contours%20of%20organs%20at%20risk%20on%20non-contrast%20CT%20images&focus=1 2023 | K220264 https://fda.innolitics.com/device/K220264?doc=summary&hl=5%3Ain%20the%20head%20and%20neck%20region&focus=1 : providing initial contours of organs at risk in the head and neck region https://fda.innolitics.com/device/K220264?doc=summary&hl=5%3Ain%20the%20head%20and%20neck%20region&focus=1 on non-contrast CT images | providing initial contours of organs at risk on non-contrast CT images | | 17 | TomTec Image-Arena Applications K071232 https://fda.innolitics.com/device/K071232?doc=summary&hl=8%3Aanalysis%20of%20the%20left%20ventricle%20in%20heart%20failure%20patients&focus=1 2007 | K040546 https://fda.innolitics.com/device/K040546?doc=summary&hl=3%3Ageneral%20purpose%20digital%20medical%20image%20processing%20tool&focus=1 : intended as a general purpose digital medical image processing tool https://fda.innolitics.com/device/K040546?doc=summary&hl=3%3Ageneral%20purpose%20digital%20medical%20image%20processing%20tool&focus=1 for cardiology, radiology, neurology | software packages for analysis of the left ventricle in heart failure patients https://fda.innolitics.com/device/K071232?doc=summary&hl=8%3Asoftware%20packages%20for%20analysis%20of%20the%20left%20ventricle%20in%20heart%20failure%20patients%2C%20to%20analyze%20pathologies%20related%20to%20the%20Mitral%20Valve%20and%20for%20analysis%20of%20the%20right%20ventricle&focus=1 , to analyze pathologies related to the Mitral Valve https://fda.innolitics.com/device/K071232?doc=summary&hl=8%3Asoftware%20packages%20for%20analysis%20of%20the%20left%20ventricle%20in%20heart%20failure%20patients%2C%20to%20analyze%20pathologies%20related%20to%20the%20Mitral%20Valve%20and%20for%20analysis%20of%20the%20right%20ventricle&focus=1 and for analysis of the right ventricle https://fda.innolitics.com/device/K071232?doc=summary&hl=8%3Asoftware%20packages%20for%20analysis%20of%20the%20left%20ventricle%20in%20heart%20failure%20patients%2C%20to%20analyze%20pathologies%20related%20to%20the%20Mitral%20Valve%20and%20for%20analysis%20of%20the%20right%20ventricle&focus=1 | | 18 | Cedara I-ReadMammo K040468 https://fda.innolitics.com/device/K040468 2004 | K022881 https://fda.innolitics.com/device/K022881 : primary diagnostic review and planning through flexible and interactive manipulation of multi-modality softcopy images | primary diagnostic review and planning … including the use of prosthetic template overlays, and including mammography https://highlight.innolitics.com/v/m0sU747wXEB5 h=1 | | 19 | GE 12SL ECG Analysis Program K060833 https://fda.innolitics.com/device/K060833?doc=summary&hl=1%3Aambulances%20and%20patient&focus=1 2006 | K042177 https://fda.innolitics.com/device/K042177?doc=summary&hl=2%3Ain%20a%20hospital%20or%20medical%20professional's%20facility&focus=1 : under the direct supervision of a licensed medical professional in a hospital or medical professional's facility https://fda.innolitics.com/device/K042177?doc=summary&hl=2%3Ain%20a%20hospital%20or%20medical%20professional's%20facility&focus=1 | intended for use in hospitals, outpatient clinics, emergency departments, and out-of-hospital sites such as ambulances and patient's homes https://fda.innolitics.com/device/K060833?doc=summary&hl=1%3Aintended%20for%20use%20in%20hospitals%2C%20outpatient%20clinics%2C%20emergency%20departments%2C%20and%20out-of-hospital%20sites%20such%20as%20ambulances%20and%20patient's%20homes&focus=1 | | 20 | Hi-D Imaging 4TAVR K261535 https://fda.innolitics.com/device/K261535?doc=summary&hl=6%3Afemoral%20arteries&focus=1 2026 | K241984 https://fda.innolitics.com/device/K241984 : including aorta, left ventricle, left atrium, myocardium, right ventricle, and pulmonary artery | including the aortic valve and femoral arteries https://fda.innolitics.com/device/K261535?doc=summary&hl=6%3Aincluding%20the%20aortic%20valve%20and%20femoral%20arteries&focus=1 … Automatic detection of abdominal aorta, left and right common iliac https://fda.innolitics.com/device/K261535?doc=summary&hl=6%3AAutomatic%20detection%20of%20abdominal%20aorta%2C%20left%20and%20right%20common%20iliac&focus=1 | | 21 | ScanNav Anatomy Peripheral Nerve Block K232787 https://fda.innolitics.com/device/K232787?doc=summary&hl=4%3AFemoral%20block&focus=1 2023 | DEN220024 https://fda.innolitics.com/device/DEN220024 : Supraclavicular level brachial plexus, Longitudinal suprainguinal fascia iliaca plane | Supraclavicular level brachial plexus, Longitudinal suprainguinal fascia iliaca plane, Femoral block https://fda.innolitics.com/device/K232787?doc=summary&hl=4%3AFemoral%20block&focus=1 | | 22 | Visage PACS/CS 5.0 K072205 https://fda.innolitics.com/device/K072205?doc=summary&hl=3%3AOnly%20DICOM%20for%20presentation%20images%20can%20be%20used%20on%20an%20FDA%20approved%20monitor%20for%20mammography%20for%20primary%20image%20diagnosis&focus=1 2007 | K062490 https://fda.innolitics.com/device/K062490 : Integration with other hospital information systems HIS, RIS, CIS is provided via special interfaces | Integration with other hospital information systems HIS, RIS, CIS is provided via special interfaces … Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis https://fda.innolitics.com/device/K072205?doc=summary&hl=3%3AOnly%20DICOM%20for%20presentation%20images%20can%20be%20used%20on%20an%20FDA%20approved%20monitor%20for%20mammography%20for%20primary%20image%20diagnosis&focus=1 | | 23 | Scenium 1.1 K061545 https://fda.innolitics.com/device/K061545?doc=summary&hl=3%3APET%20and%20SPECT%20scans&focus=1 2006 | K042863 https://fda.innolitics.com/device/K042863 : pathologies taken from PET scans … derived from FDG-PET studies | pathologies taken from PET and SPECT https://fda.innolitics.com/device/K061545?doc=summary&hl=3%3Apathologies%20taken%20from%20PET%20and%20SPECT%20scans&focus=1 scans … derived from FDG-PET and SPECT https://fda.innolitics.com/device/K061545?doc=summary&hl=3%3Aderived%20from%20FDG-PET%20and%20SPECT%20studies&focus=1 studies | | 24 | BriefCase-Triage K251406 https://fda.innolitics.com/device/K251406?doc=summary&hl=4%3ACT%20chest%2C%20abdomen%2C%20or%20chest%2Fabdomen%20exams&focus=1 2025 | K222329 https://fda.innolitics.com/device/K222329?doc=summary&hl=3%3Athat%20include%20the%20chest&focus=1 : analysis of CT exams with contrast CTA and CT with contrast that include the chest https://fda.innolitics.com/device/K222329?doc=summary&hl=3%3Athat%20include%20the%20chest&focus=1 | analysis of CT chest, abdomen, or chest/abdomen exams <https://fda.innolitics.com/device/K251406?doc=summary&hl=4%3Aanalysis%20of%20CT%20chest%2C%20abdomen%2C%20or%20chest%2Fabdomen%20exams%20with%20contrast%20 CTA%20and%20CT%20with%20contrast &focus=1 with contrast CTA and CT with contrast | In three of the four largest changes, the same manufacturer already held the added indications under another clearance. Annalise Enterprise adds pneumothorax, tension pneumothorax and vertebral compression fracture to a predicate that triaged pleural effusion and pneumoperitoneum. Annalise already held clearances for those findings. K213941 https://fda.innolitics.com/device/K213941 covers pneumothorax and tension pneumothorax, and K222268 https://fda.innolitics.com/device/K222268 covers vertebral compression fracture. The K250831 summary states that the test dataset " was previously acquired K213941, K222268 and K222179 <https://fda.innolitics.com/device/K250831?doc=summary&hl=11%3Awas%20previously%20acquired%20 K213941%2C%20K222268%20and%20K222179 &focus=1 ". The Stethophone Pro summary cites Stethophone K231551 https://fda.innolitics.com/device/K231551?doc=summary&hl=3%3Aprofessional%20or%20lay%20users%20in%20a%20clinical%20or%20nonclinical%20environment&focus=1 as a reference device. K231551 is cleared for professional or lay users in a clinical or nonclinical environment. The Stethophone Pro summary states that the features " are now available for OTC use https://fda.innolitics.com/device/K252595?doc=summary&hl=6%3Aare%20now%20available%20for%20OTC%20use&focus=1 ". syngo.via MI Workflows VB40A names Scenium VE20A https://fda.innolitics.com/device/K173597 as a reference device and adds the Scenium indications to the workflow product. Against the cited predicate, these three changes are among the four largest in the cohort. Against the manufacturer's existing clearances, they combine indications FDA had already cleared. The search of each manufacturer's earlier clearances found no such overlap in the other 21. Seventeen of the 24 changes fall in three dimensions. Six extend the device to new anatomy, such as the femoral block region in ScanNav. Six add an imaging input, such as MR for VisAble.IO https://fda.innolitics.com/device/K240773 . Five add a function or output, such as flow measurement in AI4CMR. Two add clinical findings, two add a use environment or user, and two add a patient population. One changes the claim wording. The claim type stays the same in 23 of the 24. A triage device remains a triage device, and a viewer remains a viewer. The remaining clearance is the Glytec G+ System, whose wording changes from recommending a dose to regulating an infusion. The case section below describes it. Before September 13, 2019, 8 of 237 clearances 3.4% score 5 or higher. After that date, 16 of 191 8.4% do Fisher's exact test, p = 0.03 . Both clearances that score 7 are from 2025. The eight earlier clearances show that FDA cleared indications changes as Special 510 k s under the earlier policy. GE's 12SL ECG Analysis Program extended use to ambulances and patients' homes in 2006, and Cedara added primary diagnosis of mammography in 2004. AI-flagged devices are 117 of the 428 clearances, and FDA decided 112 of the 117 after the guidance. Eleven AI-flagged clearances 9.4% score 5 or higher, against 13 of 311 4.2% for the other SaMD p = 0.06 . Among clearances decided after the guidance, the shares are 11 of 112 9.8% for AI-flagged devices and 5 of 79 6.3% for the others p = 0.44 . The data does not separate an AI effect from the change in era. Eleven of the 24 summaries report performance testing on patient images or recordings. Annalise Enterprise reports a standalone study of 3,252 cases from four US sites. ScanNav reports 183 ultrasound scans for the femoral block region, and Hi-D Imaging reports 289 CT scans for the aortic root and 85 for vascular access. The other 13 summaries report software verification and validation or bench testing only. No summary describes its testing as a prospective clinical study. Three of the summaries that tested on patient images place that testing outside clinical testing. Imbio https://fda.innolitics.com/device/K241847 states that " No clinical testing was conducted https://highlight.innolitics.com/v/9xsSkjtSnFsj h=3 ". Hi-D Imaging states that " Clinical testing was not relied upon https://fda.innolitics.com/device/K261535?doc=summary&hl=10%3AClinical%20testing%20was%20not%20relied%20upon&focus=1 ". VisAble.IO https://fda.innolitics.com/device/K240773 lists its segmentation results under " Performance testing Bench <https://fda.innolitics.com/device/K240773?doc=summary&hl=9%3APerformance%20testing%20 Bench &focus=1 ". One summary reports data collected during live use. Exo reports that " 186 abdomen scans were acquired by 12 users https://fda.innolitics.com/device/K260217?doc=summary&hl=10%3A186%20abdomen%20scans%20were%20acquired%20by%2012%20users&focus=1 " with the quality feedback running in real time. The predicate, Annalise Enterprise CXR Triage Trauma K222179 https://fda.innolitics.com/device/K222179 , triaged adult chest X-rays for pleural effusion and pneumoperitoneum. The Special 510 k lists five findings in one device. It sets the population at 22 years or older and names CR and DX as the modalities. The three added findings match two earlier Annalise clearances, K213941 and K222268. The claim type stays computer-aided triage under 21 CFR 892.2080 https://fda.innolitics.com/regulation/892.2080 . The summary reports a standalone study of 3,252 cases and states that the test dataset was previously acquired under the three earlier clearances. FDA's guidance example treats a new nodule feature on chest X-ray software as unsuitable for a Special 510 k . The Annalise clearance differs from that example on the public record. FDA had already cleared each finding in the manufacturer's earlier submissions, and the test data came from those submissions. The predicate, Stethophone Pro K240901, offered murmur detection to clinicians and was for use in " environments where health care is provided by clinicians https://fda.innolitics.com/device/K240901?doc=summary&hl=4%3Aenvironments%20where%20health%20care%20is%20provided%20by%20clinicians&focus=1 ". The Special 510 k adds nonclinical environments and over-the-counter use by lay users when the automatic analysis is not available. The summary reports bench testing only. The added uses match the reference device K231551. The predicate, AirStrip ONE Web Client K160862 https://fda.innolitics.com/device/K160862 , displayed near real-time waveforms and patient data remotely and allowed consultation requests. The Special 510 k adds alarm communication management that suppresses non-critical secondary alarms. It also adds historic waveforms and additional data sources. The summary reports software validation, code analysis, vulnerability scans, network testing and interoperability verification. The predicate, ADAS 3D K191125, covered visualization of scar from ischemic heart disease on MR and CT and excluded use to identify ablation regions. The Special 510 k adds non-ischemic heart disease and use before and during electrophysiology procedures. It replaces the ablation exclusion with a statement that the clinical significance for arrhythmia treatment is not established. The summary states that the device " is identical to the ADAS 3D device cleared under K191125 <https://fda.innolitics.com/device/K210850?doc=summary&hl=7%3Ais%20identical%20to%20the%20ADAS%203D%20device%20cleared%20under%20 K191125 &focus=1 " and that only the indications and precautions changed. The summary reports no clinical data. The predicate, Glucommander Plus K061110 https://fda.innolitics.com/device/K061110?doc=summary&hl=1%3Acalculate%20and%20recommend%20a%20dose%20of%20saline%2C%20glucose%2C%20and%20insulin&focus=1 , states that the software will "calculate and recommend a dose of saline, glucose, and insulin". The 2010 Special 510 k states that the system will " regulate the infusion of I.V. fluids, through an I.V. infusion pump https://fda.innolitics.com/device/K101344?doc=summary&hl=2%3Ainfusion%20pump%2C%20and%20drive%20the%20blood%20glucose%20level&focus=1 ". The new indications statement no longer lists the predicate's exclusions for insulin allergy and patients under 18. The summary does not describe a connection between the software and a pump. Both clearances use the drug dose calculator classification, and the new indications still describe the output as recommended guidance for trained personnel. The summary reports no performance data. The record shows a change in wording. The record does not establish that the software controls a pump. The highest score in this cohort is 7, and three of the four largest changes combine indications the manufacturer already held. In the changes that are new to the manufacturer, the device gains an anatomical region, an imaging input or an output, and the claim type stays the same. No SaMD Special 510 k in the record changes the clinical purpose of the device. The higher share after September 2019 is consistent with the change in FDA's stated test. Under the earlier policy, FDA routinely converted a Special 510 k that changed the indications. Under the current guidance, FDA asks whether a well-established method exists to evaluate the change. The comparison is observational. Software devices and their indications statements also changed over the same period. The evidence in the summaries is consistent with the guidance. The guidance names indications changes supported by clinical, animal or cadaver data as unsuitable for a Special 510 k . No summary describes a prospective clinical study. Eleven report testing on patient images or recordings, and three of those place that testing outside clinical testing. The eight clearances before 2019 show that FDA cleared indications changes through this pathway before the policy changed, at a lower rate. The scores come from AI models that read the indications text and the predicate numbers in public 510 k summaries. The three checks changed two of the 25 highest-scoring clearances, and the lower bands did not receive those checks. A change that appears in the labeling outside the indications statement is not measured. The SaMD flag defines the cohort, so software embedded in hardware is outside it. The search of a manufacturer's earlier clearances matches wording, so it can miss an earlier clearance that describes the same use in different words. Most SaMD Special 510 k s keep the predicate's indications for use or change the wording only. One in 18 makes a material change, and the share is higher since the 2019 guidance. Three of the four largest changes combine indications the manufacturer already held under its own clearances. The other material changes add anatomy, an imaging input, a function, a user or a population inside an unchanged claim type. The summaries support them with bench testing or testing on existing patient images. No SaMD Special 510 k in the record changes the device's clinical purpose. Source: FDA Device Explorer by Innolitics https://fda.innolitics.com/ , records as of October 27, 2026, with 510 k summary text retrieved November 5 and November 10, 2026. The full scored dataset of 434 clearances, including the six exclusions, is available from Innolitics.