510(k) Report

Devices descending from K001520

17 later devices reach Alpha Omega Dual Cooler-Heater through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052601Stockert Heater-Cooler System 3TSorin Group Deutschland GmbH2006418
+1K014241Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500DAlsius Corp.2003116
+2K212657Quantum Heater-CoolerSpectrum Medical, Ltd.20220—
+2K191402Heater-Cooler System 3TLivanova Deutschland, GmbH202011
+2K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc.201634
+2K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc.2015421
+2K140012Sorin FlexthermSorin Group Deutschland GmbH20140—
+2K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation20106—
+2K051912Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A…Alsius Corp.20050—
+2K033623Celsius Control SystemInnercool Therapies, Inc.20042—
+3K220635Heater-Cooler System 3TLivanova Deutschland, GmbH20220—
+3K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20212—
+3K141139Solex Intravascular Heat Exchange CatheterZoll Circulation20144—
+3K080908Innercool Therapies, Inc., Rapidblue SystemInnercool Therapies, Inc.- A Delaware Corporation200811
+4K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20230—
+4K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20221—
+4K152946TempedySeiratherm GmbH20160—