510(k) Report

Devices descending from K020825

120 later devices reach King of Hearts Express + AF Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+1K103706The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc.20111—
+1K111745King of Hearts Express AF Cardiac Event RecorderCard Guard Scientific Survival, Ltd.20110—
+1K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc.201126—
+1K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc.200828—
+1K072385Heartevent, Model atDiagnostic Devices Pty, Ltd.20080—
+1K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc.200740—
+1K063609River- 1 Electrocardiograph (Ecg) Recorder and TransmitterShl Telemedicine International, Ltd.200717—
+1K052767Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc.200647—
+1K053378Loop Recorder Vitaphone, 3100 SeriesTms Telemedizinische Systeme GmbH20062—
+1K042108Vista PlusNovacor200546—
+2K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+2K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Boston Scientific Corporation20203—
+2K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+2K150614Reveal LINQMedtronic, Inc.201515—
+2K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+2K143503BioMonitorBiotronik, Inc.20159—
+2K142352CardiacLinxRoss Medical Technology, Inc.20150—
+2K140847Cardiospy Ecg Holter SystemsLabtech Kft.20141—
+2K140933Alivecor Heart MonitorAliveCor, Inc.2014281
+2K132960BiomonitorBiotronik, Inc.201410—
+2K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+2K132206Melys Atrial Fibrillation Screening MonitorAdvanced Fluidics, LLC20147—
+2K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+2K100383Vitaphone. Model 100 BTVitasystems GmbH20101—
+2K091579Foresee HomeNotal Vision, Ltd.20094—
+2K080047Cardiosen'cShl Telemedicine International, Ltd.200811—
+2K080337Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2DMicrolife Corp.200812—
+2K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc.200730—
+3K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+3K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.202241
+3K201456Scan MonitorWithings SA202161
+3K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.20211—
+3K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.202111
+3K210608LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation20210—
+3K190574Patient Assistant Model PA97000Medtronic, Inc.20190—
+3K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+3K182030Faros MobileBittium Biosignals, Ltd.20180—
+3K173872FibriCheckQompium NV20186—
+3K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—
+3K160809Reveal LINQMedtronic, Inc.201612—
+3K160689Reveal LINQMedtronic, Inc.20161—
+3K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+3K151013Vitaphone Tele ECG Loop RecorderVitasystems GmbH20150—
+3K142743AliveCor Heart MonitorAliveCor, Inc.201519—
+3K142672AliveCor Heart MonitorAliveCor, Inc.20144—
+3K121738Myvisiontrack (TM)Vital Art and Science Incorporated20133—
+3K122161SJM ConfirmSt Jude Medical20124—
+3K113514SmartheartShl Telemedicine International, Ltd.201210—
+3K112845Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20113—
+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—
+4K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation20250—
+4K243305Masimo W1Masimo Corporation20250—
+4K232804FibriCheckQompium NV20241—
+4K232512Masimo W1Masimo Corporation20232—
+4K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.202331
+4K230812Withings Scan Monitor 2.0Withings20230—
+4K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc.202301
+4K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm…Medtronic, Inc.20230—
+4K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)Microlife Intellectual Property GmbH20230—
+4K221260CSF-3Cardiacsense20231—
+4K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+4K201208Halo AF Detection SystemLivmor20200—
+4K200738Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20200—
+4K192415Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20202—
+4K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+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—
+4K180157QT ECGQT Medical, Inc.20182—
+4K171937Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20181—
+4K171816Kardia Band SystemAliveCor, Inc.201712—
+4K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc.20170—
+4K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20170—
+4K162855Reveal LINQMedtronic, Inc.2017111
+4K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, 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—
+4K143211myVision Track Model 005Vital Art and Science Incorporated20152—
+4K142476Master Caution Device MCDHealthwatch, Ltd.20156—
+5K253306BioTracker 2.0Biotracker, LLC20260—
+5K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)20260—
+5K240229Masimo W1Masimo Corporation20241—
+5K232445CSF-4 (CSF-4)Cardiacsense20240—
+5K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+5K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+5K220795QT ECGQT Medical, Inc.20221—
+5K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20220—
+5K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+5K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+5K210753KardiaMobile 6LAliveCor, Inc.20212—
+5K202228Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc.20210—
+5K193348Blood Pressure MonitorShenzhen Viatom Technology Co., Ltd.20200—
+5K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+5K181823KardiaAIAliveCor, Inc.20196—
+5K182456Study WatchVerily Life Sciences, LLC20193—
+5K181998CardioBand ECG Event RecorderSamsung Strategy and Innovation Center (Ssic)20180—
+5K173248CardioskinBioserenity Sas20180—