510(k) Report

Devices descending from K914085

224 later devices reach HMS-5000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K163065T3 SoftwareEtiometry, Inc.201715—
+6K163665MATRx plusZephyr Sleep Technologies20173—
+6K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+6K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+6K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+6K150494Proteus Digital Health Feedback DeviceProteus Digital Health, Inc.20153—
+6K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+6K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+6K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+6K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+6K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+6K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+6K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+7K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+7K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+7K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K251088Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc.20250—
+7K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+7K242447Falcon HSTCompumedics Limited20250—
+7K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+7K241397HinscopeHinlab Sas20240—
+7K241216myAirResmed Corp20242—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+7K230386SpassageQSpass, Inc.20231—
+7K223073AlioAlio, Inc.20230—
+7K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+7K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+7K222550Current Health SystemCurrent Health, Ltd.20221—
+7K211305ANNE OneSibel, Inc.20216—
+7K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+7K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+7K202868LifeSignals Multi-Parameter Remote Monitoring PlatformLifesignals, Inc.20213—
+7K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+7K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+7K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+7K191620Vitls PlatformVitls, Inc.20202—
+7K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+7K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2…Vitalconnect, Inc.202001
+7K192624ApneaTrakCadwell Industries, Inc.20200—
+7K190273T3 Platform softwareEtiometry, Inc.201914—
+7K183052ID-Cap SystemEtectrx, Inc.20190—
+7K190792BB-613WPBiobeat Technologies, Ltd.201912—
+7K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+7K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.20199—
+7K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+7K181996MATRx PlusZephyr Sleep Technologies20182—
+7K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+7K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+7K152659V10Mediana Co., Ltd.20162—
+7K152043Diagnostic Station DS20Schiller AG20161—
+7K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—
+7K151776Central Venous Pressure SystemMespere Lifesciences, Inc.20150—
+7K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+7K140430740 SelectCas Medical Systems, Inc.20141—
+8K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+8K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+8K250624myAirResmed Corp20251—
+8K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+8K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+8K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+8K240558NavoycdsAlgodx AB20240—
+8K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+8K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+8K232915EpiMonitorEmpatica S.r.l.20241—
+8K214115MightySat -OTCMasimo Corporation20241—
+8K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+8K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+8K231506Current Health SystemCurrent Health, Ltd.20230—
+8K223711ANNE OneSibel Health, Inc.20234—
+8K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+8K221530ANNE PediatricSibel, Inc.20220—
+8K213911Microstream CO2 NanoPodCovidien, LLC20220—
+8K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+8K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+8K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+8K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+8K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+8K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+8K202306T3 Platform softwareEtiometry, Inc.202013—
+8K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+8K191925MATRx PlusZephyr Sleep Technologies20191—
+8K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc.20192—
+8K181352Loop SystemSpry Health, Inc.201910—
+8K170497V10Mediana Co., Ltd.201711
+8K170182Cardiovit FT-1Schiller AG20170—
+8K150620740 SelectCas Medical Systems, Inc.201501
+9K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+9K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+9K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—
+9K250515EpiMonitorEmpatica S.r.l.20250—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K243837iBSMIorbit Digital Technologies Private Limited20250—
+9K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+9K242842ANNE View, Central HubSibel Health, Inc.20251—