FDA PCCP Tracker
Every FDA-authorized Predetermined Change Control Plan, updated monthly from public FDA records.
All authorizations
155
PCCP authorizations
45%
AI/SaMD
70 devices
Last 90 days
21
new authorizations
48%
AI/SaMD
10 devices
Last updated: 2026-07-21
Authorizations by Panel
AI/SaMD PCCP authorizations by clinical panel
All PCCP authorizations
Showing 70 AI/SaMD PCCPs · 85 other PCCPs hidden —
Therapixel
Permits compatibility expansion to additional hardware
2026-06-26 · 510(k) · Radiology
Siemens Medical Solutions USA, Inc.
Permits model retraining with additional data
2026-06-25 · 510(k) · Radiology
Brainomix Limited
Permits model retraining with additional data
2026-06-12 · 510(k) · Radiology
Mighty Oak Medical
Permits model retraining with additional data
2026-06-11 · 510(k) · Radiology
Covidien, LLC
2026-06-04 · 510(k) · Gastroenterology, Urology
Tyto Care , Ltd.
Permits model retraining with additional data
2026-06-02 · 510(k) · Anesthesiology
Smart Alfa Teknoloji San. Ve Tic. A.S.
Permits input/output expansion to compatible devices
2026-05-21 · 510(k) · Radiology
DeepHealth, Inc.
Permits input/output expansion to compatible devices
2026-05-21 · 510(k) · Radiology
Subtle Medical, Inc.
Permits model retraining with additional data
2026-05-14 · 510(k) · Radiology
Artera, Inc.
Permits iterative model updates
2026-05-04 · 510(k) · Pathology
Siemens Healthcare GmbH
Permits model retraining with additional data
2026-04-10 · 510(k) · Radiology
Anumana, Inc.
Permits input/output expansion to compatible devices
2026-04-07 · 510(k) · Cardiovascular
Anumana, Inc.
Permits model retraining with additional data
2026-03-28 · 510(k) · Cardiovascular
Mim Software, Inc.
Permits model retraining with additional data
2026-03-27 · 510(k) · Radiology
Tyto Care , Ltd.
Permits input/output expansion to compatible devices
2026-03-17 · De Novo · Ear, Nose, Throat
Exo Imaging
Permits model retraining with additional data
2026-02-24 · 510(k) · Radiology
Ever Fortune.Ai, Co., Ltd.
Permits model retraining with additional data
2026-01-28 · 510(k) · Radiology
Qure.Ai Technologies
Permits algorithm architecture changes
2026-01-16 · 510(k) · Radiology
AliveCor, Inc.
Permits model retraining with additional data
2026-01-09 · 510(k) · Cardiovascular
Updoc, Inc.
Permits defined post-clearance changes
2025-12-23 · 510(k) · Anesthesiology
Csd Labs
Permits compatibility expansion to additional hardware
2025-12-19 · 510(k) · Cardiovascular
Ultrasight , Ltd.
Permits model retraining with additional data
2025-12-18 · 510(k) · Radiology
Ultrasight , Ltd.
Permits model retraining with additional data
2025-12-17 · 510(k) · Radiology
Ceribell, Inc.
Permits model retraining with additional data
2025-12-08 · 510(k) · Neurology
Resmed Corp
Permits model retraining with additional data
2025-12-05 · 510(k) · Anesthesiology
Mighty Oak Medical
Permits model retraining with additional data
2025-12-02 · 510(k) · Radiology
A2z Radiology Ai, Inc.
Permits algorithm architecture changes
2025-11-24 · 510(k) · Radiology
Ceribell, Inc.
Permits model retraining with additional data
2025-11-21 · 510(k) · Neurology
Imvaria, Inc.
Permits algorithm architecture changes
2025-11-07 · 510(k) · Radiology
Axial Medical Printing Limited
Permits model retraining with additional data
2025-09-18 · 510(k) · Radiology
Beijing Infervision Healthcare Medical Technology Co., Ltd.
Permits algorithm architecture changes
2025-09-15 · 510(k) · Radiology
Diagnoly
Permits model retraining with additional data
2025-09-12 · 510(k) · Radiology
Apple, Inc.
Permits model retraining with additional data
2025-09-11 · 510(k) · Cardiovascular
Springbok, Inc. (Dba Springbok Analytics)
Permits model retraining with additional data
2025-09-09 · 510(k) · Radiology
Velmeni, Inc.
Permits model retraining with additional data
2025-09-02 · 510(k) · Radiology
Medtronic Minimed, Inc.
Permits compatibility expansion to additional hardware
2025-08-29 · 510(k) · Clinical Chemistry
Therapixel
Permits model retraining with additional data
2025-08-22 · 510(k) · Radiology
Artera, Inc.
Permits compatibility expansion to additional hardware
2025-07-31 · De Novo · Pathology
Anumana, Inc.
Permits iterative model updates
2025-07-28 · 510(k) · Cardiovascular
HeartFlow, Inc.
Permits model retraining with additional data
2025-07-18 · 510(k) · Cardiovascular
Therapixel
Permits compatibility expansion to additional hardware
2025-07-03 · 510(k) · Radiology
Empatica S.r.l.
Permits algorithm architecture changes
2025-06-06 · 510(k) · Cardiovascular
Brightheart
Permits model retraining with additional data
2025-06-05 · 510(k) · Radiology
Tandem Diabetes Care, Inc.
Permits compatibility expansion to additional hardware
2025-05-21 · 510(k) · Clinical Chemistry
Clarius Mobile Health Corp.
Permits model retraining with additional data
2025-05-08 · 510(k) · Radiology
Brightheart
Permits model retraining with additional data
2025-05-07 · 510(k) · Radiology
Clarius Mobile Health Corp.
Permits model retraining with additional data
2025-04-16 · 510(k) · Radiology
Cognoa, Inc.
Permits model retraining with additional data
2025-04-11 · 510(k) · Neurology
Ceribell, Inc.
Permits model retraining with additional data
2025-04-09 · 510(k) · Neurology
Tyto Care , Ltd.
Permits model retraining with additional data
2025-04-07 · 510(k) · Anesthesiology
Deski
Permits compatibility expansion to additional hardware
2025-04-04 · 510(k) · Radiology
Siemens Healthcare GmbH
Permits model retraining with additional data
2025-04-03 · 510(k) · Radiology
Subtle Medical, Inc.
Permits input/output expansion to compatible devices
2025-02-12 · 510(k) · Radiology
Caption Health, Inc.
Permits model retraining with additional data
2025-01-15 · 510(k) · Radiology
Imvaria, Inc.
Permits model retraining with additional data
2025-01-10 · 510(k) · Radiology
Ge Medical Systems Israel, Functional Imaging
Permits compatibility expansion to additional hardware
2025-01-03 · 510(k) · Radiology
Icad, Inc.
Permits compatibility expansion to additional hardware
2024-11-08 · 510(k) · Radiology
Epitel, Inc.
Permits model retraining with additional data
2024-10-17 · 510(k) · Neurology
Therapixel
Permits compatibility expansion to additional hardware
2024-10-02 · 510(k) · Radiology
Overjet, Inc.
Permits model retraining with additional data
2024-08-27 · 510(k) · Radiology
Exo Imaging
Permits algorithm architecture changes
2024-08-05 · 510(k) · Radiology
Mighty Oak Medical
2024-07-12 · 510(k) · Radiology
Clarius Mobile Health Corp.
Permits algorithm architecture changes
2024-06-14 · 510(k) · Radiology
Mriguidance B.V.
Permits model retraining with additional data
2024-03-01 · 510(k) · Radiology
Epitel, Inc.
Permits model retraining with additional data
2024-01-03 · 510(k) · Neurology
Anumana, Inc.
2023-09-28 · 510(k) · Cardiovascular
Caption Health
Permits routine software and change management updates
2020-09-18 · 510(k) · Radiology
Bay Labs, Inc.
Permits model retraining with additional data
2020-02-07 · De Novo · Radiology
Browse the PCCP database
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Methodology
Data source.This tracker queries the openFDA 510(k) API — live, authoritative FDA data covering both 510(k) clearances and De Novo authorizations. It covers every calendar year back to 2020, the period following passage of FDORA (December 2022), which created section 515C of the FD&C Act and established PCCPs as a formal regulatory pathway.
How PCCPs are identified. PCCP authorization is not a structured field in any FDA database. Each cleared 510(k) summary or De Novo decision summary PDF is fetched from accessdata.fda.gov and searched for Predetermined Change Control Plan language. A device is marked as having a PCCP only when that language appears in the public document.
AI/SaMD classification. Devices are classified as AI/SaMD, AI hardware, or non-AI using a three-tier heuristic: FDA-established AI product codes (QIH, QAS, QFM, etc.), device name keywords (algorithm, machine learning, CADe/CADt, etc.), and LLM review of the cleared device description. All classifications are manually reviewed before publication. The AI/SaMD classifications have been cross-validated against FDA's official AI-Enabled Medical Devices list (cutoff December 2025): every AI/SaMD PCCP cleared through that date appears on FDA's list, with zero false positives.
Why some PCCP types show as “Unknown.” FDA regulations permit applicants to file either a 510(k) Summary or a 510(k) Statement. A Summary publishes the full cleared device description; a Statement publishes only a short decision letter confirming clearance. For Statement filings, the PCCP exists and is confirmed by the clearance letter, but its specific contents are not publicly disclosed. The full PCCP document is only obtainable via FOIA request. As of this snapshot, about 46 devices in this tracker show an Unknown PCCP type: roughly 18 are Statement filings whose contents are not public, and the rest are cases where the type could not be determined from the available document.
Known limitations. PMA supplements are not currently covered. Very recent authorizations may be missing until FDA posts their public documents. The PCCP type and category labels are editorial classifications based on public documents — they are not official FDA designations.
Maintained by Sentir Health — post-market monitoring infrastructure for FDA-cleared AI.
This tracker is for informational purposes only. It is not regulatory or legal advice, and it is not affiliated with or endorsed by the U.S. Food and Drug Administration.