510(k) Report

Devices descending from K051419

9 later devices reach Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092807Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103Augustine Biomedical & Design, LLC20096—
+1K080763Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HTTalley Medical20080—
+1K061902Cosytherm, Models NCM1, NCM2, NCB1, CCU1, CRU1Inditherm Medical20060—
+2K132454Vitaheat Patient Warming SystemVitaheat Medical, LLC20130—
+2K094056Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC20104—
+3K201779HotDog Temperature Management ControllerAugustine Temperature Management202034
+4K220941HotDog Temperature Management SystemAugustine Temperature Management202224
+5K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC202314
+6K232627HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC20240—