510(k) Report

Devices descending from K130921

30 later devices reach Alivecor Heart Monitor Otc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252474Withings BeamO (SCT02)Withings20250—
+1K140933Alivecor Heart MonitorAliveCor, Inc.2014281
+2K201456Scan MonitorWithings SA202161
+2K142743AliveCor Heart MonitorAliveCor, Inc.201519—
+2K142672AliveCor Heart MonitorAliveCor, Inc.20144—
+3K243305Masimo W1Masimo Corporation20250—
+3K232512Masimo W1Masimo Corporation20232—
+3K230812Withings Scan Monitor 2.0Withings20230—
+3K221260CSF-3Cardiacsense20231—
+3K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+3K183319Triangle SystemAliveCor, Inc.20193—
+3K182579Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc.20192—
+3K182040Coala Heart MonitorCoala Life AB20190—
+3K171816Kardia Band SystemAliveCor, Inc.201712—
+3K142468Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth…Cardiac Insight, Inc.20150—
+4K240229Masimo W1Masimo Corporation20241—
+4K232445CSF-4 (CSF-4)Cardiacsense20240—
+4K210753KardiaMobile 6LAliveCor, Inc.20212—
+4K202228Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc.20210—
+4K193348Blood Pressure MonitorShenzhen Viatom Technology Co., Ltd.20200—
+4K181823KardiaAIAliveCor, Inc.20196—
+4K182456Study WatchVerily Life Sciences, LLC20193—
+4K181998CardioBand ECG Event RecorderSamsung Strategy and Innovation Center (Ssic)20180—
+5K231424HeartBeam AIMIGo (TM) SystemHeartbeam, Inc.20240—
+5K220350KardiaMobile 6LAliveCor, Inc.20220—
+5K200884B-Secur HeartKey Software LibraryB-Secur, Ltd.20200—
+5K201985KardiaAIAliveCor, Inc.20200—
+5K192415Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20202—
+6K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20220—
+6K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—