510(k) Report

Devices descending from K974149

122 later devices reach Ambulatory X-12 Telemetry Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150289Cardioline HD+Cardioline S.P.A20153—
+1K141020Surveyor S4 Mobile MonitorMortara Instrument, Inc.20142—
+1K093211Carecenter MDCardiac Science Corporation20101—
+1K081800T12S Telemetry TransmitterMortara Instrument, Inc.200831
+1K032882Recom Battery-Operated Ambulatory Digital Wireless Ecg Monitor, Model 100Recom Managed Systems, Inc.20040—
+1K030795Lifesyne SystemsGmp/Companies, Inc.20031093
+1K993643Nexsystem Ambulatory Patient Monitor Model Nex 100Nexan Telemed, Ltd.19990—
+2K223670MESI mTablet ECG Diagnostic System, MESI mTablet ECGMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.20230—
+2K220526HD+12, HD+15Cardioline S.P.A202301
+2K182297Surveyor S2Mortara Instrument, Inc.20190—
+2K171019ScioCardio ECG TransmitterSynergen Technology Labs, LLC20180—
+2K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc.201601
+2K123217CardeascreenCardea Associates, Inc.20130—
+2K113054EquivitalHidalgo Limited201271—
+2K100040BioharnessZephyr Technology Corporation20103—
+2K090610Hospira Vital Signs Wireless Monitoring SystemHospira, Inc.20099—
+2K061993Equivital, Model EQ-01Hidalgo Limited200699—
+3K142476Master Caution Device MCDHealthwatch, Ltd.20156—
+3K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc.201470—
+3K113045BioharnessZephyr Technology Corporation20122—
+3K120253Elcam Vital Signs Wireless System (VSWS)Elcam Medical Acal20120—
+3K102229Pulmotrack 2020 SystemKarmelsonix20110—
+3K081140VisensiaObs Medical200822—
+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—
+4K173248CardioskinBioserenity Sas20180—
+4K171244PhysiotraceNimbleheart, Inc.20170—
+4K161431SimplECGNanowear, Inc.20165—
+4K152973Dyna-Vision Telemonitoring SystemTechmedic Development International B.V.20160—
+4K152258T3 SoftwareEtiometry, Inc.201616—
+4K150992Vios Monitoring SystemVios Medical, Inc.20157—
+4K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.201543—
+4K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+4K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+4K110953Visensia, Visensia with AlertObs Medical201117—
+5K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+5K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio20223—
+5K201669SimpleSENSENanowear, Inc.20203—
+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—
+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—
+6K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+6K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+6K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+6K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+6K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+6K241397HinscopeHinlab Sas20240—
+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—
+6K212160SimpleSENSE PlatformNanowear, Inc.20211—
+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—
+6K190792BB-613WPBiobeat Technologies, Ltd.201912—
+6K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+6K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.20199—
+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—
+7K223711ANNE OneSibel Health, Inc.20234—
+7K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+7K221530ANNE PediatricSibel, Inc.20220—
+7K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+7K202306T3 Platform softwareEtiometry, Inc.202013—
+7K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc.20192—
+8K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+8K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+8K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+8K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+8K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+8K252981EmbraceMiniEmpatica S.r.l.20251—
+8K250515EpiMonitorEmpatica S.r.l.20250—
+8K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—