510(k) Report

Devices descending from K040605

100 later devices reach Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113054EquivitalHidalgo Limited201271—
+1K061993Equivital, Model EQ-01Hidalgo Limited200699—
+2K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc.201470—
+2K100040BioharnessZephyr Technology Corporation20103—
+2K081140VisensiaObs Medical200822—
+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—
+3K152973Dyna-Vision Telemonitoring SystemTechmedic Development International B.V.20160—
+3K152258T3 SoftwareEtiometry, Inc.201616—
+3K150992Vios Monitoring SystemVios Medical, Inc.20157—
+3K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.201543—
+3K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+3K113045BioharnessZephyr Technology Corporation20122—
+3K110953Visensia, Visensia with AlertObs Medical201117—
+4K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+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—
+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—
+4K171244PhysiotraceNimbleheart, Inc.20170—
+4K170973VitalWatch Software User InterfaceVitalconnect, Inc.20171—
+4K163065T3 SoftwareEtiometry, Inc.201715—
+4K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+4K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+5K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+5K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+5K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+5K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+5K241397HinscopeHinlab Sas20240—
+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—
+5K190792BB-613WPBiobeat Technologies, Ltd.201912—
+5K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+5K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.20199—
+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—
+6K202306T3 Platform softwareEtiometry, Inc.202013—
+6K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc.20192—
+7K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+7K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+7K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+7K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+7K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+7K252981EmbraceMiniEmpatica S.r.l.20251—
+7K250515EpiMonitorEmpatica S.r.l.20250—
+7K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+7K243837iBSMIorbit Digital Technologies Private Limited20250—
+7K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+7K242842ANNE View, Central HubSibel Health, Inc.20251—
+7K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+7K240251ANNE ChestSibel Health, Inc.20240—
+7K240305ANNE LimbSibel Health, Inc.20240—
+7K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+7K213230T3 Platform SoftwareEtiometry, Inc.202212—
+7K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D…Vitalconnect, Inc.20201—
+8K231276SmartCardia 7L PlatformSmartcardia SA20230—
+8K223578T3 Platform softwareEtiometry, Inc.20232—
+8K213423T3 Platform softwareEtiometry, Inc.20232—
+8K222463EchoGo Heart FailureUltromics Limited20227—
+9K251293CardioVisionIcardio.Ai20250—
+9K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+9K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+9K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+9K223905Vivio® LVEDP SystemAvicena, LLC20230—
+9K231335Cleerly ISCHEMIACleerly, Inc.20230—
+10K254066Etiometry PlatformEtiometry, Inc.20260—
+10K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+10K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—