510(k) Report

Devices descending from K983626

121 later devices reach King of Hearts Express II & King of Hearts Express EZ II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020825King of Hearts Express + AF MonitorCard Guard Scientific Survival, Ltd.2002120—
+2K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+2K103706The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc.20111—
+2K111745King of Hearts Express AF Cardiac Event RecorderCard Guard Scientific Survival, Ltd.20110—
+2K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc.201126—
+2K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc.200828—
+2K072385Heartevent, Model atDiagnostic Devices Pty, Ltd.20080—
+2K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc.200740—
+2K063609River- 1 Electrocardiograph (Ecg) Recorder and TransmitterShl Telemedicine International, Ltd.200717—
+2K052767Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc.200647—
+2K053378Loop Recorder Vitaphone, 3100 SeriesTms Telemedizinische Systeme GmbH20062—
+2K042108Vista PlusNovacor200546—
+3K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+3K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Boston Scientific Corporation20203—
+3K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+3K150614Reveal LINQMedtronic, Inc.201515—
+3K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+3K143503BioMonitorBiotronik, Inc.20159—
+3K142352CardiacLinxRoss Medical Technology, Inc.20150—
+3K140847Cardiospy Ecg Holter SystemsLabtech Kft.20141—
+3K140933Alivecor Heart MonitorAliveCor, Inc.2014281
+3K132960BiomonitorBiotronik, Inc.201410—
+3K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+3K132206Melys Atrial Fibrillation Screening MonitorAdvanced Fluidics, LLC20147—
+3K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+3K100383Vitaphone. Model 100 BTVitasystems GmbH20101—
+3K091579Foresee HomeNotal Vision, Ltd.20094—
+3K080047Cardiosen'cShl Telemedicine International, Ltd.200811—
+3K080337Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2DMicrolife Corp.200812—
+3K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc.200730—
+4K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+4K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.202241
+4K201456Scan MonitorWithings SA202161
+4K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.20211—
+4K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.202111
+4K210608LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation20210—
+4K190574Patient Assistant Model PA97000Medtronic, Inc.20190—
+4K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+4K182030Faros MobileBittium Biosignals, Ltd.20180—
+4K173872FibriCheckQompium NV20186—
+4K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—
+4K160809Reveal LINQMedtronic, Inc.201612—
+4K160689Reveal LINQMedtronic, Inc.20161—
+4K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+4K151013Vitaphone Tele ECG Loop RecorderVitasystems GmbH20150—
+4K142743AliveCor Heart MonitorAliveCor, Inc.201519—
+4K142672AliveCor Heart MonitorAliveCor, Inc.20144—
+4K121738Myvisiontrack (TM)Vital Art and Science Incorporated20133—
+4K122161SJM ConfirmSt Jude Medical20124—
+4K113514SmartheartShl Telemedicine International, Ltd.201210—
+4K112845Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20113—
+4K100763Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watch BP Home N…Microlife Intellectual Property GmbH20101—
+4K101275Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib…Microlife Intellectual Property GmbH20106—
+5K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation20250—
+5K243305Masimo W1Masimo Corporation20250—
+5K232804FibriCheckQompium NV20241—
+5K232512Masimo W1Masimo Corporation20232—
+5K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.202331
+5K230812Withings Scan Monitor 2.0Withings20230—
+5K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc.202301
+5K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm…Medtronic, Inc.20230—
+5K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)Microlife Intellectual Property GmbH20230—
+5K221260CSF-3Cardiacsense20231—
+5K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+5K201208Halo AF Detection SystemLivmor20200—
+5K200738Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20200—
+5K192415Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20202—
+5K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+5K190927Oscillometric Blood Pressure MonitorRudolf Riester GmbH20190—
+5K183319Triangle SystemAliveCor, Inc.20193—
+5K182579Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc.20192—
+5K182040Coala Heart MonitorCoala Life AB20190—
+5K180157QT ECGQT Medical, Inc.20182—
+5K171937Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20181—
+5K171816Kardia Band SystemAliveCor, Inc.201712—
+5K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc.20170—
+5K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20170—
+5K162855Reveal LINQMedtronic, Inc.2017111
+5K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20170—
+5K142468Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth…Cardiac Insight, Inc.20150—
+5K143341Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20154—
+5K143211myVision Track Model 005Vital Art and Science Incorporated20152—
+5K142476Master Caution Device MCDHealthwatch, Ltd.20156—
+6K253306BioTracker 2.0Biotracker, LLC20260—
+6K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)20260—
+6K240229Masimo W1Masimo Corporation20241—
+6K232445CSF-4 (CSF-4)Cardiacsense20240—
+6K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+6K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+6K220795QT ECGQT Medical, Inc.20221—
+6K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20220—
+6K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+6K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+6K210753KardiaMobile 6LAliveCor, Inc.20212—
+6K202228Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc.20210—
+6K193348Blood Pressure MonitorShenzhen Viatom Technology Co., Ltd.20200—
+6K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+6K181823KardiaAIAliveCor, Inc.20196—
+6K182456Study WatchVerily Life Sciences, LLC20193—
+6K181998CardioBand ECG Event RecorderSamsung Strategy and Innovation Center (Ssic)20180—