510(k) Report

Devices descending from K883603

9 later devices reach Sarns Temp. Control and Monitor System (TCM II) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071521Terumo HX2 Temperature Management SystemTerumo Cardiovascular Systems Corp.200707
+1K031544Heater Cooler Unit, Model Hcu 30Jostra AB200374
+2K130300Heater-Cooler Unit Hcu 40Maquet Cardiopulmonary, AG20130—
+2K122813Hemotherm Model 400CE Cooler/Heater SystemCincinnati Sub-Zero Products, Inc.201206
+2K052601Stockert Heater-Cooler System 3TSorin Group Deutschland GmbH2006418
+3K212657Quantum Heater-CoolerSpectrum Medical, Ltd.20220—
+3K191402Heater-Cooler System 3TLivanova Deutschland, GmbH202011
+3K140012Sorin FlexthermSorin Group Deutschland GmbH20140—
+4K220635Heater-Cooler System 3TLivanova Deutschland, GmbH20220—