510(k) Report

Devices descending from K091461

27 later devices reach Bernoulli Management System, Oxinet Iii and Lifegard Vue through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140339Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien2014222
+1K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG2010312
+2K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG20240—
+2K171056WAVE Clinical PlatformExcel Medical Electronics, LLC20181—
+2K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG20170—
+2K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien201601
+2K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG201519
+2K142732T3 SoftwareEtiometry, Inc.201518—
+3K250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical20260—
+3K152258T3 SoftwareEtiometry, Inc.201616—
+3K151715T3 SoftwareEtiometry, Inc.201517—
+4K163065T3 SoftwareEtiometry, Inc.201715—
+5K190273T3 Platform softwareEtiometry, Inc.201914—
+6K202306T3 Platform softwareEtiometry, Inc.202013—
+7K213230T3 Platform SoftwareEtiometry, Inc.202212—
+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—