510(k) Report

Devices descending from K991786

64 later devices reach Mars Unity Workstation with Heart Rate Variability (HRV) Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093141Mars Holter Analysis WorkstationGe Medical Systems Information Technologies20097—
+1K051026Mars Holter Analysis WorkstationGe Medical Systems Information Technologies20058—
+1K042108Vista PlusNovacor200546—
+1K042148Heart Rate Turbulence Analysis TechnologiesGe Medical Syst. Information Technologies20040—
+1K040313HRV ToolsDel Mar Reynolds Medical, Ltd.20040—
+1K021230HEROMedical Decision Networks20036—
+2K142551QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC20150—
+2K140847Cardiospy Ecg Holter SystemsLabtech Kft.20141—
+2K132437Mars Holter Analysis WorkstationGe Medical Systems Information Technologies, Inc.20136—
+2K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+2K081473Hero, Version 2.0Medical Predictive Science Corp.20082—
+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—
+2K062068Intelwave Heart Rate Variability System, Version 1.0Intelwave, LLC20061—
+3K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+3K182030Faros MobileBittium Biosignals, Ltd.20180—
+3K162023CardioDay V2.5Getemed Medizin- Und Informationstechnik AG20171—
+3K151787Holter SystemEdan Instruments, Inc.20162—
+3K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc.20150—
+3K143503BioMonitorBiotronik, Inc.20159—
+3K132960BiomonitorBiotronik, Inc.201410—
+3K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+3K122161SJM ConfirmSt Jude Medical20124—
+3K111601HEROMedical Predictive Science Corp.20111—
+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—
+4K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+4K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+4K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.20250—
+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—
+4K180242HeRO Symphony, HeRO ES, HeRO solo/duetMedical Predictive Science Corporation20180—
+4K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+4K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+4K150614Reveal LINQMedtronic, Inc.201515—
+4K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+4K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+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—
+5K190574Patient Assistant Model PA97000Medtronic, Inc.20190—
+5K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+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
+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—
+7K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+7K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+8K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+9K230375Biomonitor IVBiotronik, Inc.20231—
+10K261074Biomonitor IV (471155)Biotronik, Inc.20260—