510(k) Report

Devices descending from K093244

20 later devices reach Unique Temp Warming Blankets, Model 8001140XXX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123002Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc.201319—
+2K142732T3 SoftwareEtiometry, Inc.201518—
+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—