510(k) Report

Devices descending from K991045

138 later devices reach Mini-Logger Series 2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052489ActiheartRespironics, Inc.2005132—
+1K033534VitalsenseMini-Mitter Co., Inc.200410—
+2K113054EquivitalHidalgo Limited201271—
+2K102499DuofertilityCambridge Temperature Concepts, Ltd.20111—
+2K100040BioharnessZephyr Technology Corporation20103—
+2K093976Raisin Personal MonitorProteus Biomedical, Inc.201012—
+2K083185Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG System, Model S1Cadi Scientific Pte.Ltd20096—
+2K061993Equivital, Model EQ-01Hidalgo Limited200699—
+2K060919ActicalRespironics, Inc.2006361
+2K061870Vitalsense XHRRespironics, Inc.20060—
+3K230298Celsi MonitorHadleigh Health Technologies20230—
+3K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc.201470—
+3K122337OvusenseFertility Focus, Ltd.20130—
+3K131009Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20136—
+3K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+3K113045BioharnessZephyr Technology Corporation20122—
+3K110015Vitalsens, Aingeal, V-PodIntelesens Limited20114—
+3K081140VisensiaObs Medical200822—
+4K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+4K220111RespiraSensePmd Solutions20221—
+4K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+4K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+4K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+4K171244PhysiotraceNimbleheart, Inc.20170—
+4K152973Dyna-Vision Telemonitoring SystemTechmedic Development International B.V.20160—
+4K152258T3 SoftwareEtiometry, Inc.201616—
+4K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+4K150992Vios Monitoring SystemVios Medical, Inc.20157—
+4K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.201543—
+4K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+4K151027zensor systemIntelesens Limited20150—
+4K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+4K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd.20141—
+4K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+4K133263Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20144—
+4K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+4K131524Proteus Patch Including Ingestible SensorProteus Digital Health, Inc.20130—
+4K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+4K110953Visensia, Visensia with AlertObs Medical201117—
+5K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+5K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+5K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+5K223463Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc.20231—
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio20223—
+5K200690LifeSignals ECG Remote Monitoring Patch PlatformLifesignals, Inc.20201—
+5K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+5K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+5K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+5K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+5K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+5K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+5K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+5K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+5K173510BioStamp nPointMc10, Inc.20180—
+5K172329Patient Status EngineIsansys Lifecare, Ltd.201810—
+5K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.201711—
+5K170973VitalWatch Software User InterfaceVitalconnect, Inc.20171—
+5K163065T3 SoftwareEtiometry, Inc.201715—
+5K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+5K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+5K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+5K150494Proteus Digital Health Feedback DeviceProteus Digital Health, Inc.20153—
+6K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+6K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+6K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K251088Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc.20250—
+6K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+6K241397HinscopeHinlab Sas20240—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+6K230386SpassageQSpass, Inc.20231—
+6K223073AlioAlio, Inc.20230—
+6K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+6K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+6K222550Current Health SystemCurrent Health, Ltd.20221—
+6K211305ANNE OneSibel, Inc.20216—
+6K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+6K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+6K202868LifeSignals Multi-Parameter Remote Monitoring PlatformLifesignals, Inc.20213—
+6K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+6K191620Vitls PlatformVitls, Inc.20202—
+6K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2…Vitalconnect, Inc.202001
+6K190273T3 Platform softwareEtiometry, Inc.201914—
+6K183052ID-Cap SystemEtectrx, Inc.20190—
+6K190792BB-613WPBiobeat Technologies, Ltd.201912—
+6K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+6K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.20199—
+6K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+7K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+7K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+7K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+7K240558NavoycdsAlgodx AB20240—
+7K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+7K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+7K232915EpiMonitorEmpatica S.r.l.20241—
+7K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+7K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+7K231506Current Health SystemCurrent Health, Ltd.20230—