510(k) Report

Devices descending from K992410

73 later devices reach Actitrac through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081485SomnowatchSomnomedics GmbH20080—
+1K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc.200730—
+1K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc.200740—
+1K040554Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256Manufacturing Technology, Inc.200427—
+1K010997PAM-RLIndividual Monitoring Systems, Inc.20010—
+2K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+2K143512ActiSpec Activity MonitorSleep Modus, Inc.20150—
+2K143503BioMonitorBiotronik, Inc.20159—
+2K132960BiomonitorBiotronik, Inc.201410—
+2K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+2K122161SJM ConfirmSt Jude Medical20124—
+2K111514SBV2, Multicharger Model MC10V2Sleep Performance D.B.A. Fatigue Science20112—
+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—
+2K080545ActitrainerActigraph, LLC200823—
+3K233987Veraband™Arbor Medical Innovations, LLC20240—
+3K233618Oxevision Sleep DeviceOxehealth Limited20240—
+3K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.202241
+3K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.20211—
+3K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.202111
+3K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Boston Scientific Corporation20203—
+3K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+3K181077ActiGraph CentrePoint Insight WatchActigraph201810—
+3K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+3K151784ActTrustCondor Instruments Ltda. - Epp20160—
+3K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+3K150614Reveal LINQMedtronic, Inc.201515—
+3K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+3K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20149—
+3K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+4K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.202331
+4K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+4K231532ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLC20231—
+4K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc.202301
+4K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm…Medtronic, Inc.20230—
+4K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+4K213519Rune Labs Tremor Transducer SystemRune Labs, Inc.20224—
+4K210608LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation20210—
+4K190574Patient Assistant Model PA97000Medtronic, Inc.20190—
+4K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+4K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+4K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—
+4K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc.20170—
+4K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20170—
+4K161717Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20163—
+4K160809Reveal LINQMedtronic, Inc.201612—
+4K160689Reveal LINQMedtronic, Inc.20161—
+5K253055Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)Nordic Kinetics AB20260—
+5K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation20250—
+5K243513DCM (PW-DCM)Pneumowave, Ltd.20250—
+5K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+5K232915EpiMonitorEmpatica S.r.l.20241—
+5K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+5K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+5K221772NeuroRPMNew Touch Digital, Inc.20230—
+5K220820Parky AppH2o Bilisim Yazilim20223—
+5K211887Personal Kinetigraph (PKG) System Gen 2 PlusGkc Manufacturing Pty, Ltd.20221—
+5K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+5K162855Reveal LINQMedtronic, Inc.2017111
+5K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20170—
+6K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—
+6K262515Kneu Platform (V2)Kneu Health Digital, Ltd.20260—
+6K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+6K252981EmbraceMiniEmpatica S.r.l.20251—
+6K250515EpiMonitorEmpatica S.r.l.20250—
+6K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+6K250153Neu PlatformNeuhealth Digital, Ltd.20251—
+6K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+6K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+6K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+7K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+8K230375Biomonitor IVBiotronik, Inc.20231—
+9K261074Biomonitor IV (471155)Biotronik, Inc.20260—