510(k) Report

Devices descending from K010949

85 later devices reach 2010 Plus Holter for Windows through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbH20250—
+1K070260Star ST and Arrhythmia Software, Release H.0Philips Medical Systems20077—
+1K051026Mars Holter Analysis WorkstationGe Medical Systems Information Technologies20058—
+1K042108Vista PlusNovacor200546—
+1K031517Zargis Acoustic CardioscanZargis Medical Corp.200419—
+2K143432Cardio-TriTestCardio-Phoenix, Inc.20151—
+2K140847Cardiospy Ecg Holter SystemsLabtech Kft.20141—
+2K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+2K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+2K093141Mars Holter Analysis WorkstationGe Medical Systems Information Technologies20097—
+2K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+2K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+2K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc.200730—
+2K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc.200740—
+2K060197Zargis Acoustic Cardioscan (Zac), Model Zac 6.28Zargis Medical Corp.200615—
+2K052283Heart STG System and SoftwareStethographics, Inc.200511—
+3K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+3K182790Cardio-TriTest v6.5Cardio-Phoenix, Inc.20180—
+3K182030Faros MobileBittium Biosignals, Ltd.20180—
+3K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+3K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+3K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+3K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+3K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+3K143503BioMonitorBiotronik, Inc.20159—
+3K132960BiomonitorBiotronik, Inc.201410—
+3K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+3K132437Mars Holter Analysis WorkstationGe Medical Systems Information Technologies, Inc.20136—
+3K122161SJM ConfirmSt Jude Medical20124—
+3K121617SensicardiacDiacoustic Medical (Pty)201210—
+3K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+3K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc.201126—
+3K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc.200828—
+4K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.202241
+4K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.20211—
+4K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.202111
+4K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Boston Scientific Corporation20203—
+4K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+4K162023CardioDay V2.5Getemed Medizin- Und Informationstechnik AG20171—
+4K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+4K151787Holter SystemEdan Instruments, Inc.20162—
+4K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc.20150—
+4K150614Reveal LINQMedtronic, Inc.201515—
+4K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+4K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+4K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+4K131287CardiosleeveRijuven Corp20131—
+5K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+5K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+5K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.20250—
+5K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.202331
+5K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+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—
+5K210608LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation20210—
+5K201299HD StethHd Medical, Inc.20200—
+5K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+5K190574Patient Assistant Model PA97000Medtronic, Inc.20190—
+5K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+5K181988eMurmur IDCsd Labs GmbH20197—
+5K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+5K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—
+5K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc.20170—
+5K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20170—
+5K160809Reveal LINQMedtronic, Inc.201612—
+5K160689Reveal LINQMedtronic, Inc.20161—
+6K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation20250—
+6K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+6K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+6K230823AusculThing ACCAusculthing OY20230—
+6K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+6K220766eMurmur Heart AICsd Labs GmbH20221—
+6K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+6K162855Reveal LINQMedtronic, Inc.2017111
+6K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20170—
+7K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—
+7K252284eMurmur Heart AICsd Labs20250—
+7K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+7K240901StethophoneSparrow Acoustics, Inc.20241—
+7K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+7K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+8K252595Stethophone ProSparrow Acoustics, Inc.20250—
+8K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+9K230375Biomonitor IVBiotronik, Inc.20231—
+10K261074Biomonitor IV (471155)Biotronik, Inc.20260—