510(k) Report

Devices descending from K914085

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991045Mini-Logger Series 2000Mini-Mitter Co., Inc.1999138—
+1K973920StardustRespironics, Inc.1998100—
+1K972829Cricket 2000 Recording Pulse OximeterRespironics, Inc.19970—
+2K052573Stardust IIRespironics, Inc.200502
+2K052489ActiheartRespironics, Inc.2005132—
+2K021845Stardust II, Model 1011176Respironics, Inc.200429—
+2K033534VitalsenseMini-Mitter Co., Inc.200410—
+2K000253Silent Night VSleep Solutions, Inc.200069—
+3K113054EquivitalHidalgo Limited201271—
+3K102499DuofertilityCambridge Temperature Concepts, Ltd.20111—
+3K110486AccusomNovasom, Inc.20111—
+3K100040BioharnessZephyr Technology Corporation20103—
+3K093976Raisin Personal MonitorProteus Biomedical, Inc.201012—
+3K083575Apnealink Plus, Model: 22328Resmed Germany, Inc.200927—
+3K083185Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG System, Model S1Cadi Scientific Pte.Ltd20096—
+3K070326Noga Automated Sleep Study Scoring and Data Management SystemWidemed, Ltd.20072—
+3K061993Equivital, Model EQ-01Hidalgo Limited200699—
+3K060919ActicalRespironics, Inc.2006361
+3K061870Vitalsense XHRRespironics, Inc.20060—
+3K042745Lifescreen ApneaDel Mar Reynolds Medical, Inc.2005631
+4K230298Celsi MonitorHadleigh Health Technologies20230—
+4K220012BresoDX1Bresotec, Inc.20220—
+4K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc.201470—
+4K140124S9 EloueraResmed Corp20148—
+4K132371Easycare OnlineResmed, Ltd.20138—
+4K131932Apnealink ProResmed Germany, Inc.20138—
+4K122337OvusenseFertility Focus, Ltd.20130—
+4K131009Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20136—
+4K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+4K113045BioharnessZephyr Technology Corporation20122—
+4K111314Morpheus OXWidemed, Ltd.20110—
+4K110001Spacelabs Pathfinder SL Holter AnalyzerSpacelabs Healthcare, Ltd.201161
+4K110015Vitalsens, Aingeal, V-PodIntelesens Limited20114—
+4K083325N-600X with SPD, Oximax N-600XCovidien200953—
+4K081861Holter LX AnalysisNorth East Monitoring, Inc.20080—
+4K081140VisensiaObs Medical200822—
+4K073269HC1000P Sleep Diagnosis Software SystemHypnocore, Ltd.20080—
+4K070855Sleep QualityDynadx Corporation20080—
+5K261360EasyCare Tx 2Resmed Corp20260—
+5K251889myAirResmed Corp20260—
+5K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+5K220111RespiraSensePmd Solutions20221—
+5K201921Spacelabs Lifescreen PRO AnalyzerSpacelabs Healthcare, Ltd.20210—
+5K203126S10 KirraResmed Pty, Ltd.20200—
+5K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+5K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+5K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+5K171244PhysiotraceNimbleheart, Inc.20170—
+5K160836Menai SystemResmed, Ltd.20166—
+5K152973Dyna-Vision Telemonitoring SystemTechmedic Development International B.V.20160—
+5K152258T3 SoftwareEtiometry, Inc.201616—
+5K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+5K152356SapphireRespironics, Inc.20164—
+5K150992Vios Monitoring SystemVios Medical, Inc.20157—
+5K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.201543—
+5K151901AirViewResmed, Ltd.20151—
+5K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+5K151027zensor systemIntelesens Limited20150—
+5K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+5K143272ApneaLink AirResmed Germany, Inc.20157—
+5K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd.20141—
+5K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+5K133263Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20144—
+5K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+5K131524Proteus Patch Including Ingestible SensorProteus Digital Health, Inc.20130—
+5K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+5K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+5K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+5K120773Nellcor Bedside SPO2 Patient Monitoring SystemCovidien, LLC201261
+5K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+5K110569Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Inovise Medical, Inc.20114—
+5K110953Visensia, Visensia with AlertObs Medical201117—
+6K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+6K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+6K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+6K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+6K242485EveryWareBreas Medical AB20250—
+6K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+6K242798AirmodHeroic Faith International, Ltd.20251—
+6K223463Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc.20231—
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+6K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio20223—
+6K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+6K200565GalapogosResmed Corp20213—
+6K200690LifeSignals ECG Remote Monitoring Patch PlatformLifesignals, Inc.20201—
+6K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+6K183226Care Orchestrator EssenceRespironics, Inc.20190—
+6K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+6K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+6K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+6K181053Care OrchestratorRespironics, Inc.20191—
+6K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+6K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+6K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+6K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+6K173510BioStamp nPointMc10, Inc.20180—
+6K172329Patient Status EngineIsansys Lifecare, Ltd.201810—
+6K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+6K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.201711—
+6K170973VitalWatch Software User InterfaceVitalconnect, Inc.20171—