510(k) Report

Devices descending from K974149

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243837iBSMIorbit Digital Technologies Private Limited20250—
+8K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+8K242842ANNE View, Central HubSibel Health, Inc.20251—
+8K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+8K240251ANNE ChestSibel Health, Inc.20240—
+8K240305ANNE LimbSibel Health, Inc.20240—
+8K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+8K213230T3 Platform SoftwareEtiometry, Inc.202212—
+8K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D…Vitalconnect, Inc.20201—
+9K231276SmartCardia 7L PlatformSmartcardia SA20230—
+9K223578T3 Platform softwareEtiometry, Inc.20232—
+9K213423T3 Platform softwareEtiometry, Inc.20232—
+9K222463EchoGo Heart FailureUltromics Limited20227—
+10K251293CardioVisionIcardio.Ai20250—
+10K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+10K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+10K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+10K223905Vivio® LVEDP SystemAvicena, LLC20230—
+10K231335Cleerly ISCHEMIACleerly, Inc.20230—
+11K254066Etiometry PlatformEtiometry, Inc.20260—
+11K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+11K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—