510(k) Report

Devices descending from K001149

57 later devices reach Augustine Medical Bair Huuger, Model 750 Total Temperature Management… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1713733M Bair Hugger Model 675 Total Temperature Management System3M Company20173—
+1K162562Opt-Shield Air, Supine; Opt-Shield, LithotomyBcg Medical, LLC20170—
+1K141686Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket…Smith Medical Asd, Inc.20141—
+1K102856Sirocco Thermal Regulating SystemGalmaz Biotech S.L.20110—
+1K101705Mistral-Air Warming SystemThe Surgical Company International B.V.201021
+1K080763Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HTTalley Medical20080—
+1K062794PRN Thermalcare, Model 3000American Healthcare Products, Inc.20062—
+1K052392Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC200635—
+1K041686Bair Hugger Temperature Management SystemArizant Healthcare, Inc.20047—
+1K040440HTTP System (HTTP 2001 Controller and HTTP Warm ME Blankets)Http Hypothermia Therapy20040—
+2K2106053M Bair Hugger Universal Warming Gown made with Thinsulate Insulation3M Company20210—
+2K2106033M Bair Hugger Temperature Management System (Model 675)3M Company20211—
+2K201779HotDog Temperature Management ControllerAugustine Temperature Management202034
+2K181699Level 1 Convective WarmerSmiths Medical Asd, Inc.20180—
+2K171234Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company)20171—
+2K140635Cocoon Convective Warming SystemCare Essentials Pty, Ltd.201402
+2K113705Pintler Patient Warming SystemPintler Medical201201
+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—
+2K053645Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc.200664
+3K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life20260—
+3K231211Medline ComfortTemp Patient Warming SystemMedline Industries, LP20230—
+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—
+3K060865Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc.200646
+4K260278ThermAffyx (TM) Patient Safety SystemStihler Electronic GmbH20260—
+4K260903Hot Pink Pad Warming SystemXodus Medical, Inc.20260—
+4K232502Cocoon Convective Warming System, Model CWS7000Care Essentials Pty, Ltd.20240—
+4K232508Barrier EasyWarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC20230—
+4K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC202314
+4K142732T3 SoftwareEtiometry, Inc.201518—
+4K083336Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1…Smiths Medical Asd, Inc.20092—
+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—