510(k) Report

Devices descending from K950779

96 later devices reach Heart Rate Variability Software Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070795Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd.200716—
+1K991786Mars Unity Workstation with Heart Rate Variability (HRV) OptionGeneral Electric Medical Systems Information Techn199964—
+1K972991Monitor One NDXQmed, Inc.199831—
+2K122129Sphygmocor XcelAtcor Medical20126—
+2K110603Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH20118—
+2K092809HRV AcquireWr Medical Electronics Co.20100—
+2K093141Mars Holter Analysis WorkstationGe Medical Systems Information Technologies20097—
+2K081654HEM-9000AIOmron Healthcare, Inc.20080—
+2K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical20088—
+2K080884QHRV 1 - Health Assessment SystemMedtechs, LLC20083—
+2K071168The Portable AnsiscopeDyansys, Inc.20077—
+2K051026Mars Holter Analysis WorkstationGe Medical Systems Information Technologies20058—
+2K042108Vista PlusNovacor200546—
+2K042148Heart Rate Turbulence Analysis TechnologiesGe Medical Syst. Information Technologies20040—
+2K040313HRV ToolsDel Mar Reynolds Medical, Ltd.20040—
+2K021230HEROMedical Decision Networks20036—
+2K991831BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc.199926—
+3K241217CloudHRV™ System (100-01-001)Inmedix, Inc.20250—
+3K221742Conneqt PulseAtcor Medical20230—
+3K172431Cardiovascular AnalzyerPhysiowave, Inc.20180—
+3K142969ANI MonitorMdoloris Medical Systems Sas20160—
+3K151520Oscar 2Suntech Medical, Inc.201632
+3K142551QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC20150—
+3K140847Cardiospy Ecg Holter SystemsLabtech Kft.20141—
+3K140928ABPM7100I.E.M. GmbH20145—
+3K131916Bprosoft Casp PC SoftwareHealthstats International Pte., Ltd.20140—
+3K132437Mars Holter Analysis WorkstationGe Medical Systems Information Technologies, Inc.20136—
+3K123130Answatch Wrist Monitor Model TS-0411Taiwan Scientific Corporation20132—
+3K121266CardioscopePulsecor Limited20120—
+3K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+3K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+3K083735Ansha Autonomic Nervous System Health Assessment PlusMedtechs, LLC20092—
+3K082709Vicor PD2I Analyzer, Version 2.1Vicor Technologies, Inc.20081—
+3K081473Hero, Version 2.0Medical Predictive Science Corp.20082—
+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—
+3K062068Intelwave Heart Rate Variability System, Version 1.0Intelwave, LLC20061—
+3K993875BMT Anscore Health Management SystemBoston Medical Technologies, Inc.200017—
+4K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+4K213699CareTaker Monitor AppCaretaker Medical, LLC20220—
+4K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+4K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+4K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+4K191266VitalScan ANSMedeia, Inc.20200—
+4K182030Faros MobileBittium Biosignals, Ltd.20180—
+4K162023CardioDay V2.5Getemed Medizin- Und Informationstechnik AG20171—
+4K153557ABPM 7100, Hypertension Management SoftwareI.E.M. GmbH20160—
+4K151787Holter SystemEdan Instruments, Inc.20162—
+4K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc.20150—
+4K143503BioMonitorBiotronik, Inc.20159—
+4K132960BiomonitorBiotronik, Inc.201410—
+4K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+4K122161SJM ConfirmSt Jude Medical20124—
+4K111601HEROMedical Predictive Science Corp.20111—
+4K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc.201126—
+4K101867Vicor PD2I AnalyzerVicor Technologies, Inc.20110—
+4K101983Critical Care AssessmentCritical Patient Care, Inc.20101—
+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—
+5K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.20250—
+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—
+5K180242HeRO Symphony, HeRO ES, HeRO solo/duetMedical Predictive Science Corporation20180—
+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—