AI hardware PCCPs
15 of the 143 FDA-authorized PCCPs in this tracker are AI hardware. Here is the full list, newest first.
- K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS2026-05-21AI hardwareCompatibility expansion
- K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC2026-05-06AI hardwareRetraining
- K253976iLet ACE PumpBeta Bionics, Inc.2026-04-30AI hardwareI/O expansion
- K260212EnSite X EP SystemABBOTT MEDICAL2026-04-20AI hardwareHardware
- K252945Novasight Hybrid SystemConavi Medical, Inc.2026-04-17AI hardwareRetraining
- K253573ASTar BC G- KitQ-Linea AB2026-04-15AI hardwarePanel expansion
- K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.2026-03-02AI hardwareI/O expansion
- K252972CARTO 3 EP Navigation System V8.4Biosense Webster, Inc.2026-02-20AI hardwareRetraining
- K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed2026-02-03AI hardwareI/O expansion
- K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.2026-01-15AI hardwareI/O expansion
- K253585SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc.2026-01-14AI hardwareI/O expansion
- K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.2026-01-11AI hardwareRetraining
- K250984Maestro System (REF100)Moon Surgical2025-06-27AI hardwareRetraining
- K241368Sonicaid Team3Huntleigh Healthcare , Ltd.2025-02-03AI hardwareUnknown
- K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.2021-06-11AI hardwareRetraining
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We read the AI hardware 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.