510(k) Report

Devices descending from K914085

224 later devices reach HMS-5000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+9K240251ANNE ChestSibel Health, Inc.20240—
+9K240305ANNE LimbSibel Health, Inc.20240—
+9K232445CSF-4 (CSF-4)Cardiacsense20240—
+9K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+9K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+9K220351Polso WatchChronisense Medical, Ltd.20220—
+9K213230T3 Platform SoftwareEtiometry, Inc.202212—
+9K200695MATRx plusZephyr Sleep Technologies20200—
+9K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D…Vitalconnect, Inc.20201—
+10K231276SmartCardia 7L PlatformSmartcardia SA20230—
+10K223578T3 Platform softwareEtiometry, Inc.20232—
+10K213423T3 Platform softwareEtiometry, Inc.20232—
+10K222463EchoGo Heart FailureUltromics Limited20227—
+11K251293CardioVisionIcardio.Ai20250—
+11K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+11K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+11K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+11K223905Vivio® LVEDP SystemAvicena, LLC20230—
+11K231335Cleerly ISCHEMIACleerly, Inc.20230—
+12K254066Etiometry PlatformEtiometry, Inc.20260—
+12K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+12K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—