510(k) Report

Devices descending from K011859

13 later devices reach Klimamed Thermal Mat & Controller 95 and 55 Watts through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080763Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HTTalley Medical20080—
+1K062794PRN Thermalcare, Model 3000American Healthcare Products, Inc.20062—
+1K051419Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1Inditherm Medical20069—
+1K031728Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg Warmer…Klimamed Technologie Medizingerate GmbH200410—
+2K113705Pintler Patient Warming SystemPintler Medical201201
+2K092807Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103Augustine Biomedical & Design, LLC20096—
+2K061902Cosytherm, Models NCM1, NCM2, NCB1, CCU1, CRU1Inditherm Medical20060—
+3K132454Vitaheat Patient Warming SystemVitaheat Medical, LLC20130—
+3K094056Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC20104—
+4K201779HotDog Temperature Management ControllerAugustine Temperature Management202034
+5K220941HotDog Temperature Management SystemAugustine Temperature Management202224
+6K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC202314
+7K232627HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC20240—