510(k) Report

Devices descending from K152139

43 later devices reach Vital Connect Platform, HealthPatch MD, VitalPatch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+1K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio20223—
+1K200690LifeSignals ECG Remote Monitoring Patch PlatformLifesignals, Inc.20201—
+1K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+1K173510BioStamp nPointMc10, Inc.20180—
+1K172329Patient Status EngineIsansys Lifecare, Ltd.201810—
+1K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.201711—
+1K170973VitalWatch Software User InterfaceVitalconnect, Inc.20171—
+1K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+2K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+2K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+2K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+2K223073AlioAlio, Inc.20230—
+2K211305ANNE OneSibel, Inc.20216—
+2K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+2K202868LifeSignals Multi-Parameter Remote Monitoring PlatformLifesignals, Inc.20213—
+2K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+2K191620Vitls PlatformVitls, Inc.20202—
+2K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2…Vitalconnect, Inc.202001
+2K190792BB-613WPBiobeat Technologies, Ltd.201912—
+2K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.20199—
+3K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+3K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+3K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+3K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+3K223711ANNE OneSibel Health, Inc.20234—
+3K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+3K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+3K221530ANNE PediatricSibel, Inc.20220—
+3K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+3K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc.20192—
+4K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+4K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+4K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+4K243837iBSMIorbit Digital Technologies Private Limited20250—
+4K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+4K242842ANNE View, Central HubSibel Health, Inc.20251—
+4K240251ANNE ChestSibel Health, Inc.20240—
+4K240305ANNE LimbSibel Health, Inc.20240—
+4K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+4K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+4K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D…Vitalconnect, Inc.20201—
+5K231276SmartCardia 7L PlatformSmartcardia SA20230—