Cardiovascular PCCPs
15 of the 143 FDA-authorized PCCPs are in the Cardiovascular panel, 9 of them AI/SaMD. Here is the full list, newest first.
- K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC2026-05-06AI hardwareRetraining
- K260212EnSite X EP SystemABBOTT MEDICAL2026-04-20AI hardwareHardware
- K252945Novasight Hybrid SystemConavi Medical, Inc.2026-04-17AI hardwareRetraining
- K253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)Anumana, Inc.2026-04-07AI/SaMDI/O expansion
- K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc.2026-03-28AI/SaMDRetraining
- K252972CARTO 3 EP Navigation System V8.4Biosense Webster, Inc.2026-02-20AI hardwareRetraining
- K252589Corvair MonzaAliveCor, Inc.2026-01-09AI/SaMDRetraining
- K252284eMurmur Heart AICsd Labs2025-12-19AI/SaMDCompatibility expansion
- K250507Hypertension Notification Feature (HTNF)Apple, Inc.2025-09-11AI/SaMDRetraining
- K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc.2025-07-28AI/SaMDModel update
- K250902HeartFlow AnalysisHeartFlow, Inc.2025-07-18AI/SaMDRetraining
- K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.2025-06-06AI/SaMDArchitecture change
- K250079Ruby XL SystemPenumbra, Inc.2025-03-14Non-AIUnknown
- K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc.2023-09-28AI/SaMDUnknown
- K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.2021-06-11AI hardwareRetraining
Other panels
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We read the Cardiovascular PCCPs in this list, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.