510(k) Report

Devices descending from K001288

64 later devices reach DR180-II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102723Model 950-12L Holter Recorder Without AnalysisMemtec Corp.20103—
+1K041901SD360 Digital Recorder/SD360 Holter Digital RecorderNorth East Monitoring, Inc.20046—
+1K022540Cardio ID+(RZ153+)Rozinn Electronics, Inc.200259—
+2K181658MobileECG 2 BTMemtec Corporation20190—
+2K140847Cardiospy Ecg Holter SystemsLabtech Kft.20141—
+2K122272CardiomemGetemed Medizin- Und Informationstechnik AG20130—
+2K103706The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc.20111—
+2K061293Telaheart Digital RecorderNorth East Monitoring, Inc.20065—
+2K051686Cardiomem CM 3000-12Getemed Medizin- Und Informationstechnik AG20050—
+2K042108Vista PlusNovacor200546—
+2K032466SpiderviewEla Medical, Inc.200356—
+3K182030Faros MobileBittium Biosignals, Ltd.20180—
+3K142352CardiacLinxRoss Medical Technology, Inc.20150—
+3K142424DR300 Holter MonitorNorth East Monitoring, Inc.20143—
+3K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+3K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc.200730—
+3K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc.200740—
+3K070014Auto Detect for Telaheart DR200/E-aNorth East Monitoring, Inc.20070—
+3K043010Holter Recorder H3+Mortara Instrument, Inc.20054—
+4K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+4K152626H3+ Holter RecorderMortara Instrument, Inc.20160—
+4K151787Holter SystemEdan Instruments, Inc.20162—
+4K143503BioMonitorBiotronik, Inc.20159—
+4K132960BiomonitorBiotronik, Inc.201410—
+4K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+4K122161SJM ConfirmSt Jude Medical20124—
+4K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc.201126—
+4K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc.200828—
+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—
+5K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.202241
+5K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.20211—
+5K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.202111
+5K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Boston Scientific Corporation20203—
+5K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+5K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+5K150614Reveal LINQMedtronic, Inc.201515—
+5K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+5K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+6K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.202331
+6K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+6K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc.202301
+6K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm…Medtronic, Inc.20230—
+6K210608LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation20210—
+6K190574Patient Assistant Model PA97000Medtronic, Inc.20190—
+6K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+6K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+6K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—
+6K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc.20170—
+6K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20170—
+6K160809Reveal LINQMedtronic, Inc.201612—
+6K160689Reveal LINQMedtronic, Inc.20161—
+7K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation20250—
+7K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+7K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+7K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+7K162855Reveal LINQMedtronic, Inc.2017111
+7K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20170—
+8K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—
+8K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+8K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+9K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+10K230375Biomonitor IVBiotronik, Inc.20231—
+11K261074Biomonitor IV (471155)Biotronik, Inc.20260—