510(k) Report

Devices descending from K052767

47 later devices reach Afibalert Atrial Fibrillation Detector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140933Alivecor Heart MonitorAliveCor, Inc.2014281
+1K132206Melys Atrial Fibrillation Screening MonitorAdvanced Fluidics, LLC20147—
+1K080337Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2DMicrolife Corp.200812—
+2K201456Scan MonitorWithings SA202161
+2K173872FibriCheckQompium NV20186—
+2K142743AliveCor Heart MonitorAliveCor, Inc.201519—
+2K142672AliveCor Heart MonitorAliveCor, Inc.20144—
+2K112845Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20113—
+2K100763Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watch BP Home N…Microlife Intellectual Property GmbH20101—
+2K101275Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib…Microlife Intellectual Property GmbH20106—
+3K243305Masimo W1Masimo Corporation20250—
+3K232804FibriCheckQompium NV20241—
+3K232512Masimo W1Masimo Corporation20232—
+3K230812Withings Scan Monitor 2.0Withings20230—
+3K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)Microlife Intellectual Property GmbH20230—
+3K221260CSF-3Cardiacsense20231—
+3K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+3K201208Halo AF Detection SystemLivmor20200—
+3K200738Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20200—
+3K192415Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20202—
+3K190927Oscillometric Blood Pressure MonitorRudolf Riester GmbH20190—
+3K183319Triangle SystemAliveCor, Inc.20193—
+3K182579Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc.20192—
+3K182040Coala Heart MonitorCoala Life AB20190—
+3K171937Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20181—
+3K171816Kardia Band SystemAliveCor, Inc.201712—
+3K142468Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth…Cardiac Insight, Inc.20150—
+3K143341Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20154—
+4K253306BioTracker 2.0Biotracker, LLC20260—
+4K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)20260—
+4K240229Masimo W1Masimo Corporation20241—
+4K232445CSF-4 (CSF-4)Cardiacsense20240—
+4K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20220—
+4K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+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—
+4K152770ProBP 2400 Digital Blood Pressure DeviceMicrolife Intellectual Property GmbH201531
+5K231424HeartBeam AIMIGo (TM) SystemHeartbeam, Inc.20240—
+5K220350KardiaMobile 6LAliveCor, Inc.20220—
+5K200884B-Secur HeartKey Software LibraryB-Secur, Ltd.20200—
+5K201985KardiaAIAliveCor, Inc.20200—
+5K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20202—
+6K202729Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20210—