510(k) Report

Devices descending from K052489

132 later devices reach Actiheart through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113054EquivitalHidalgo Limited201271—
+1K100040BioharnessZephyr Technology Corporation20103—
+1K093976Raisin Personal MonitorProteus Biomedical, Inc.201012—
+1K061993Equivital, Model EQ-01Hidalgo Limited200699—
+1K060919ActicalRespironics, Inc.2006361
+1K061870Vitalsense XHRRespironics, Inc.20060—
+2K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc.201470—
+2K131009Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20136—
+2K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+2K113045BioharnessZephyr Technology Corporation20122—
+2K110015Vitalsens, Aingeal, V-PodIntelesens Limited20114—
+2K081140VisensiaObs Medical200822—
+3K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+3K220111RespiraSensePmd Solutions20221—
+3K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+3K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+3K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+3K171244PhysiotraceNimbleheart, Inc.20170—
+3K152973Dyna-Vision Telemonitoring SystemTechmedic Development International B.V.20160—
+3K152258T3 SoftwareEtiometry, Inc.201616—
+3K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+3K150992Vios Monitoring SystemVios Medical, Inc.20157—
+3K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.201543—
+3K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+3K151027zensor systemIntelesens Limited20150—
+3K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+3K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd.20141—
+3K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+3K133263Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20144—
+3K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+3K131524Proteus Patch Including Ingestible SensorProteus Digital Health, Inc.20130—
+3K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+3K110953Visensia, Visensia with AlertObs Medical201117—
+4K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+4K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+4K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+4K223463Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc.20231—
+4K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+4K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio20223—
+4K200690LifeSignals ECG Remote Monitoring Patch PlatformLifesignals, Inc.20201—
+4K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+4K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+4K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+4K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+4K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+4K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+4K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+4K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+4K173510BioStamp nPointMc10, Inc.20180—
+4K172329Patient Status EngineIsansys Lifecare, Ltd.201810—
+4K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.201711—
+4K170973VitalWatch Software User InterfaceVitalconnect, Inc.20171—
+4K163065T3 SoftwareEtiometry, Inc.201715—
+4K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+4K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+4K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+4K150494Proteus Digital Health Feedback DeviceProteus Digital Health, Inc.20153—
+5K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+5K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+5K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+5K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+5K251088Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc.20250—
+5K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+5K241397HinscopeHinlab Sas20240—
+5K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+5K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+5K230386SpassageQSpass, Inc.20231—
+5K223073AlioAlio, Inc.20230—
+5K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+5K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+5K222550Current Health SystemCurrent Health, Ltd.20221—
+5K211305ANNE OneSibel, Inc.20216—
+5K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+5K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+5K202868LifeSignals Multi-Parameter Remote Monitoring PlatformLifesignals, Inc.20213—
+5K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+5K191620Vitls PlatformVitls, Inc.20202—
+5K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2…Vitalconnect, Inc.202001
+5K190273T3 Platform softwareEtiometry, Inc.201914—
+5K183052ID-Cap SystemEtectrx, Inc.20190—
+5K190792BB-613WPBiobeat Technologies, Ltd.201912—
+5K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+5K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.20199—
+5K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+6K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+6K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+6K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+6K240558NavoycdsAlgodx AB20240—
+6K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+6K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+6K232915EpiMonitorEmpatica S.r.l.20241—
+6K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+6K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+6K231506Current Health SystemCurrent Health, Ltd.20230—
+6K223711ANNE OneSibel Health, Inc.20234—
+6K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+6K221530ANNE PediatricSibel, Inc.20220—
+6K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+6K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+6K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—