510(k) Report

Devices descending from K012223

181 later devices reach CG-2211 Selfcheck Ecg Transmitter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071228Fidelity 200 Cardiac Event RecorderSignalife, Inc.200732—
+1K063044Cardiobelt Electrode BeltMonebo Technologies, Inc.200718—
+1K052767Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc.200647—
+1K042254PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd.200599—
+1K040942VST3Biowatch Medical, Inc.200418—
+2K133703Physioglove ET SystemCommwell R&D, Ltd.20140—
+2K140933Alivecor Heart MonitorAliveCor, Inc.2014281
+2K132206Melys Atrial Fibrillation Screening MonitorAdvanced Fluidics, LLC20147—
+2K121628Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd.201331—
+2K122184Ecg CheckCardiac Designs, LLC201330—
+2K113045BioharnessZephyr Technology Corporation20122—
+2K100383Vitaphone. Model 100 BTVitasystems GmbH20101—
+2K083174HealthepodCard Guard Scientific Survival, Ltd.200915—
+2K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+2K080337Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2DMicrolife Corp.200812—
+2K063609River- 1 Electrocardiograph (Ecg) Recorder and TransmitterShl Telemedicine International, Ltd.200717—
+2K060911CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd.200644—
+2K053378Loop Recorder Vitaphone, 3100 SeriesTms Telemedizinische Systeme GmbH20062—
+2K050853PMP4 SpiroproCard Guard Scientific Survival, Ltd.20052—
+3K201456Scan MonitorWithings SA202161
+3K173872FibriCheckQompium NV20186—
+3K170506ECG Check - Universal, ECG Check - Universal PlusCardiac Designs, Inc.20170—
+3K170181PrizmaG-Medical Innovations, Ltd.20171—
+3K171244PhysiotraceNimbleheart, Inc.20170—
+3K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc.201530—
+3K151013Vitaphone Tele ECG Loop RecorderVitasystems GmbH20150—
+3K142743AliveCor Heart MonitorAliveCor, Inc.201519—
+3K142672AliveCor Heart MonitorAliveCor, Inc.20144—
+3K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+3K121617SensicardiacDiacoustic Medical (Pty)201210—
+3K112845Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20113—
+3K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+3K100763Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watch BP Home N…Microlife Intellectual Property GmbH20101—
+3K101275Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib…Microlife Intellectual Property GmbH20106—
+3K093976Raisin Personal MonitorProteus Biomedical, Inc.201012—
+3K091579Foresee HomeNotal Vision, Ltd.20094—
+3K083535Heartrak Smart EcatUniversal Medical, Inc.200817—
+3K080047Cardiosen'cShl Telemedicine International, Ltd.200811—
+3K072722Meddorna Wireless PRN Spirometer 100Meddorna, LLC20080—
+3K071995CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd.2007252
+3K060703PMP4 BP Pro Blood Pressure MonitorCard Guard Scientific Survival, Ltd.20060—
+4K243305Masimo W1Masimo Corporation20250—
+4K232670HiCardi+ H100MEZOO Co., Ltd.20240—
+4K232804FibriCheckQompium NV20241—
+4K232512Masimo W1Masimo Corporation20232—
+4K230812Withings Scan Monitor 2.0Withings20230—
+4K223049CardioSTAT® ECG Test SolutionIcentia, Inc.20230—
+4K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)Microlife Intellectual Property GmbH20230—
+4K221260CSF-3Cardiacsense20231—
+4K203638AT-Patch ECG Analysis SystemAtsens Co., Ltd.20221—
+4K210179QOCA Portable ECG Monitoring DeviceQuanta Computer, Inc.20220—
+4K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+4K202456M5 RecorderGlobal Instrumentation, LLC20200—
+4K201208Halo AF Detection SystemLivmor20200—
+4K200738Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20200—
+4K192415Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20202—
+4K190927Oscillometric Blood Pressure MonitorRudolf Riester GmbH20190—
+4K183319Triangle SystemAliveCor, Inc.20193—
+4K182579Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc.20192—
+4K182040Coala Heart MonitorCoala Life AB20190—
+4K173589PrizmaG-Medical Innovations, Ltd.20180—
+4K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL20181—
+4K171937Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20181—
+4K171816Kardia Band SystemAliveCor, Inc.201712—
+4K171936Peerbridge Cor (TM) SystemPeerbridge Health, Inc.20171—
+4K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.2017181
+4K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareCardiac Insight, Inc.20170—
+4K142468Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth…Cardiac Insight, Inc.20150—
+4K143341Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20154—
+4K141813Rhythmstar SystemRhythMedix, LLC20148—
+4K131699Emotion Ecg MobileMega Electronics, Ltd.201316—
+4K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+4K131287CardiosleeveRijuven Corp20131—
+4K131009Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20136—
+4K121738Myvisiontrack (TM)Vital Art and Science Incorporated20133—
+4K113514SmartheartShl Telemedicine International, Ltd.201210—
+4K103706The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc.20111—
+4K110015Vitalsens, Aingeal, V-PodIntelesens Limited20114—
+4K101639CG-6108 Act-IL Continuous Ecg Monitor and Arrythmia DetectorCard Guard Scientific Survival, Ltd.201022
+4K090037Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model PocketecgMedicalgorithmics SP Z.O.O.20097—
+4K081257CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd.2008182
+5K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.20260—
+5K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+5K253306BioTracker 2.0Biotracker, LLC20260—
+5K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)20260—
+5K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.20250—
+5K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+5K240229Masimo W1Masimo Corporation20241—
+5K233584RhythmStar SystemRhythMedix, LLC20241—
+5K232445CSF-4 (CSF-4)Cardiacsense20240—
+5K231620Nuubo SmartSmart Solutions Technologies SL20230—
+5K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20220—
+5K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+5K210753KardiaMobile 6LAliveCor, Inc.20212—
+5K202228Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc.20210—
+5K201299HD StethHd Medical, Inc.20200—
+5K193348Blood Pressure MonitorShenzhen Viatom Technology Co., Ltd.20200—
+5K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+5K181988eMurmur IDCsd Labs GmbH20197—
+5K181823KardiaAIAliveCor, Inc.20196—