510(k) Report

Devices descending from K991684

41 later devices reach Chillbuster Portable Electric Blanket System, Model 8001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071918Chillbuster Portable Electric Blanket, Model 8002Thermogear, Inc.20071—
+1K051336Geratherm Sos-Rescue BagR.G. Enterprises, Inc.20060—
+1K051278Geratherm Sos-Vacutherm (Thermamed Smartcare)Rg Ent., Inc.20060—
+1K022903ChillbusterMicrotek Medical, Inc.200236—
+2K083135Modification to Chillbuster Portable Electric Blanket , Model 8002Thermogear, Inc.20080—
+2K052392Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC200635—
+3K201779HotDog Temperature Management ControllerAugustine Temperature Management202034
+3K112488Hotdog Patient Warming SystemAugustine Biomedical & Design, LLC20116—
+3K093244Unique Temp Warming Blankets, Model 8001140XXXGeratherm Medical AG201020—
+3K094056Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC20104—
+3K092807Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103Augustine Biomedical & Design, LLC20096—
+4K220941HotDog Temperature Management SystemAugustine Temperature Management202224
+4K202197Astopad Patient Warming SystemStihler Electronic GmbH20202—
+4K200446STERIS Patient Warming SystemSTERIS Corporation20200—
+4K132048Barrier Easywarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC20131—
+4K132454Vitaheat Patient Warming SystemVitaheat Medical, LLC20130—
+4K123002Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc.201319—
+5K260278ThermAffyx (TM) Patient Safety SystemStihler Electronic GmbH20260—
+5K260903Hot Pink Pad Warming SystemXodus Medical, Inc.20260—
+5K232508Barrier EasyWarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC20230—
+5K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC202314
+5K142732T3 SoftwareEtiometry, Inc.201518—
+6K232627HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC20240—
+6K152258T3 SoftwareEtiometry, Inc.201616—
+6K151715T3 SoftwareEtiometry, Inc.201517—
+7K163065T3 SoftwareEtiometry, Inc.201715—
+8K190273T3 Platform softwareEtiometry, Inc.201914—
+9K202306T3 Platform softwareEtiometry, Inc.202013—
+10K213230T3 Platform SoftwareEtiometry, Inc.202212—
+11K223578T3 Platform softwareEtiometry, Inc.20232—
+11K213423T3 Platform softwareEtiometry, Inc.20232—
+11K222463EchoGo Heart FailureUltromics Limited20227—
+12K251293CardioVisionIcardio.Ai20250—
+12K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+12K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+12K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+12K223905Vivio® LVEDP SystemAvicena, LLC20230—
+12K231335Cleerly ISCHEMIACleerly, Inc.20230—
+13K254066Etiometry PlatformEtiometry, Inc.20260—
+13K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+13K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—