510(k) Report

Devices descending from K031544

7 later devices reach Heater Cooler Unit, Model Hcu 30 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130300Heater-Cooler Unit Hcu 40Maquet Cardiopulmonary, AG20130—
+1K122813Hemotherm Model 400CE Cooler/Heater SystemCincinnati Sub-Zero Products, Inc.201206
+1K052601Stockert Heater-Cooler System 3TSorin Group Deutschland GmbH2006418
+2K212657Quantum Heater-CoolerSpectrum Medical, Ltd.20220—
+2K191402Heater-Cooler System 3TLivanova Deutschland, GmbH202011
+2K140012Sorin FlexthermSorin Group Deutschland GmbH20140—
+3K220635Heater-Cooler System 3TLivanova Deutschland, GmbH20220—