510(k) Report

Devices descending from K022903

36 later devices reach Chillbuster through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052392Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC200635—
+2K201779HotDog Temperature Management ControllerAugustine Temperature Management202034
+2K112488Hotdog Patient Warming SystemAugustine Biomedical & Design, LLC20116—
+2K093244Unique Temp Warming Blankets, Model 8001140XXXGeratherm Medical AG201020—
+2K094056Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC20104—
+2K092807Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103Augustine Biomedical & Design, LLC20096—
+3K220941HotDog Temperature Management SystemAugustine Temperature Management202224
+3K202197Astopad Patient Warming SystemStihler Electronic GmbH20202—
+3K200446STERIS Patient Warming SystemSTERIS Corporation20200—
+3K132048Barrier Easywarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC20131—
+3K132454Vitaheat Patient Warming SystemVitaheat Medical, LLC20130—
+3K123002Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc.201319—
+4K260278ThermAffyx (TM) Patient Safety SystemStihler Electronic GmbH20260—
+4K260903Hot Pink Pad Warming SystemXodus Medical, Inc.20260—
+4K232508Barrier EasyWarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC20230—
+4K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC202314
+4K142732T3 SoftwareEtiometry, Inc.201518—
+5K232627HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC20240—
+5K152258T3 SoftwareEtiometry, Inc.201616—
+5K151715T3 SoftwareEtiometry, Inc.201517—
+6K163065T3 SoftwareEtiometry, Inc.201715—
+7K190273T3 Platform softwareEtiometry, Inc.201914—
+8K202306T3 Platform softwareEtiometry, Inc.202013—
+9K213230T3 Platform SoftwareEtiometry, Inc.202212—
+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—