510(k) Report

Devices descending from K052392

35 later devices reach Hot Dog Patient Warming System through their predicates, nearest generation first.

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