510(k) Report

Devices descending from K140933

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

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