510(k) Report

Devices descending from K052489

132 later devices reach Actiheart through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—