510(k) Report

Devices descending from K960167

19 later devices reach System, Thermal Regulating 74-DWJ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102856Sirocco Thermal Regulating SystemGalmaz Biotech S.L.20110—
+1K101148Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc.201022
+1K092807Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103Augustine Biomedical & Design, LLC20096—
+1K041686Bair Hugger Temperature Management SystemArizant Healthcare, Inc.20047—
+2K140635Cocoon Convective Warming SystemCare Essentials Pty, Ltd.201402
+2K132454Vitaheat Patient Warming SystemVitaheat Medical, LLC20130—
+2K123946Warmair Model 135 Hyperthermia System Including Filteredflo BlanketsCincinnati Sub-Zero Products, Inc.20130—
+2K121669Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc.20121—
+2K094056Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC20104—
+2K053645Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc.200664
+3K201779HotDog Temperature Management ControllerAugustine Temperature Management202034
+3K060865Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc.200646
+4K232502Cocoon Convective Warming System, Model CWS7000Care Essentials Pty, Ltd.20240—
+4K220941HotDog Temperature Management SystemAugustine Temperature Management202224
+4K083336Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1…Smiths Medical Asd, Inc.20092—
+5K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC202314
+5K141686Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket…Smith Medical Asd, Inc.20141—
+6K232627HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC20240—
+6K181699Level 1 Convective WarmerSmiths Medical Asd, Inc.20180—