510(k) Report

Devices descending from K854030

129 later devices reach Wrist Actigraph through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251574Sleep WatchAmbulatory Monitoring, Inc.20250—
+1K983533ActiwatchMini-Mitter Co., Inc.19991263
+1K965079Somnitor 32K Sleep Activity MonitorNeurim Pharmaceuticals, Ltd.19970—
+2K151784ActTrustCondor Instruments Ltda. - Epp20160—
+2K132764Motion Watch and Pro-DiaryCamntech, Ltd.201410—
+2K060919ActicalRespironics, Inc.2006361
+2K040554Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256Manufacturing Technology, Inc.200427—
+2K992410ActitracIndividual Monitoring Systems, Inc.199973—
+2K991033Actiwatch-ScoreMini-Mitter Co., Inc.199935—
+3K233987Veraband™Arbor Medical Innovations, LLC20240—
+3K173510BioStamp nPointMc10, Inc.20180—
+3K143512ActiSpec Activity MonitorSleep Modus, Inc.20150—
+3K142476Master Caution Device MCDHealthwatch, Ltd.20156—
+3K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+3K111514SBV2, Multicharger Model MC10V2Sleep Performance D.B.A. Fatigue Science20112—
+3K093976Raisin Personal MonitorProteus Biomedical, Inc.201012—
+3K081485SomnowatchSomnomedics GmbH20080—
+3K080545ActitrainerActigraph, LLC200823—
+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—
+3K063872KinesiaCleveland Medical Devices, Inc.200710—
+3K010997PAM-RLIndividual Monitoring Systems, Inc.20010—
+4K233618Oxevision Sleep DeviceOxehealth Limited20240—
+4K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+4K220111RespiraSensePmd Solutions20221—
+4K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+4K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+4K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+4K173248CardioskinBioserenity Sas20180—
+4K181077ActiGraph CentrePoint Insight WatchActigraph201810—
+4K161431SimplECGNanowear, Inc.20165—
+4K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+4K143503BioMonitorBiotronik, Inc.20159—
+4K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20149—
+4K132960BiomonitorBiotronik, Inc.201410—
+4K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+4K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+4K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+4K131009Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20136—
+4K122161SJM ConfirmSt Jude Medical20124—
+4K110015Vitalsens, Aingeal, V-PodIntelesens Limited20114—
+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—
+5K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+5K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+5K231532ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLC20231—
+5K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+5K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.202241
+5K213519Rune Labs Tremor Transducer SystemRune Labs, Inc.20224—
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.20211—
+5K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.202111
+5K201669SimpleSENSENanowear, Inc.20203—
+5K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Boston Scientific Corporation20203—
+5K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+5K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+5K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+5K161717Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20163—
+5K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+5K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+5K151027zensor systemIntelesens Limited20150—
+5K150614Reveal LINQMedtronic, Inc.201515—
+5K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+5K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd.20141—
+5K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+5K133263Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20144—
+5K131524Proteus Patch Including Ingestible SensorProteus Digital Health, Inc.20130—
+6K253055Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)Nordic Kinetics AB20260—
+6K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K243513DCM (PW-DCM)Pneumowave, Ltd.20250—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K232915EpiMonitorEmpatica S.r.l.20241—
+6K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.202331
+6K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+6K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+6K223463Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc.20231—
+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—
+6K221772NeuroRPMNew Touch Digital, Inc.20230—
+6K220820Parky AppH2o Bilisim Yazilim20223—
+6K211887Personal Kinetigraph (PKG) System Gen 2 PlusGkc Manufacturing Pty, Ltd.20221—
+6K212160SimpleSENSE PlatformNanowear, Inc.20211—
+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—
+6K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+6K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+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—
+6K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+6K150494Proteus Digital Health Feedback DeviceProteus Digital Health, Inc.20153—
+7K262515Kneu Platform (V2)Kneu Health Digital, Ltd.20260—
+7K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+7K252981EmbraceMiniEmpatica S.r.l.20251—
+7K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation20250—