510(k) Report

Devices descending from K811742

55 later devices reach Hemotherm Model 400 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122813Hemotherm Model 400CE Cooler/Heater SystemCincinnati Sub-Zero Products, Inc.201206
+1K071341Modification to Arctic Sun Temperature Management System, Model 2000Medivance, Inc.2007201
+1K070112Rapidcool Patient Temperature Management SystemMedcool, Inc.200711—
+1K052601Stockert Heater-Cooler System 3TSorin Group Deutschland GmbH2006418
+1K012512Setpoint Endovascular Temperature Management SystemRadiant Medical200227—
+2K212657Quantum Heater-CoolerSpectrum Medical, Ltd.20220—
+2K191402Heater-Cooler System 3TLivanova Deutschland, GmbH202011
+2K140078Tecotherm Neo (T Neo)Inspiration Healthcare, Ltd.201401
+2K140012Sorin FlexthermSorin Group Deutschland GmbH20140—
+2K121720Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC20120—
+2K100585Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc.20119—
+2K101092Arctic Sun Temperature Management System, Model 5000Medivance, Inc.201083
+2K083662CriticoolMtre Advanced Technology, Ltd.2009161
+2K071358Reprieve Endovascular Temperature Therapy SystemRadiant Medical20070—
+2K063405Reprieve Endovascular Temperature Therapy SystemRadiant Medical20071—
+2K033623Celsius Control SystemInnercool Therapies, Inc.20042—
+2K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp.2003154
+2K024327Setpoint Endovascular Temperature ProbeRadiant Medical20031—
+2K023914Coaxia Flocontrol CatheterCoaxia, Inc.20036—
+2K022366Celsius Control SystemInnercool Therapies200316—
+3K220635Heater-Cooler System 3TLivanova Deutschland, GmbH20220—
+3K180375The IQoolTM Warm SystemBraincool AB20181—
+3K152266Altrix Precision Temperature Management SystemStryker Medical201631
+3K161602Arctic Sun Temperature Management SystemMedivance, Inc.201632
+3K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Medivance, Inc.201446
+3K101589Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsCincinnati Sub-Zero Products, Inc.201046
+3K090970Flocontrol , Model 1028Coaxia, Inc.20091—
+3K080908Innercool Therapies, Inc., Rapidblue SystemInnercool Therapies, Inc.- A Delaware Corporation200811
+3K080700Duoflo CatheterThermopeutix, Inc.20083—
+3K081936Solex Catheter, Model SL2593Alsius Corp.20085—
+3K052443Icy Catheter, Model IC-3893AAlsius Corp.20058—
+3K051912Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A…Alsius Corp.20050—
+3K042388Radiant Medical Endocatheter Temperature ProbeRadiant Medical20040—
+4K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.20250—
+4K242964Celsi WarmerHadleigh Health Technologies20250—
+4K232844The IQoolTM SystemBraincool AB20230—
+4K192786Gatekeeper Balloon CatheterArch Catheter, LLC20200—
+4K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc.202011
+4K180834Altrix Precision Temperature Management SystemStryker Medical201801
+4K171149Altrix Temperature Management WrapsStryker Medical20170—
+4K152946TempedySeiratherm GmbH20160—
+4K141139Solex Intravascular Heat Exchange CatheterZoll Circulation20144—
+4K120081Norm-O-Temp Hyperthermia System Incliding Blankets/PadsCincinnati Sub-Zero Products, Inc.201201
+4K112219Tapas CatheterThermopeutix, Inc.20111—
+4K110104Blanketrol II Hyper-Hypothermia Temperature Managment SystemCincinnati Sub-Zero Products, Inc.201113
+4K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation20106—
+4K093847Duflo Catheter (Heparin Coated)Thermopeutix, Inc.20100—
+4K070161Quattro Catheter Model IC4593Alsius Corp.20077—
+5K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.20250—
+5K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc.201634
+5K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc.2015421
+5K141175Renovocath RC120Renovorx, Inc.201401
+6K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20212—
+7K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20230—
+7K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20221—