Devices descending from K010338
55 later devices reach Artic Sun Temperature Management System, Model 200 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K120849 | Hybrid Arcticgel Pad | Medivance, Inc. | 2012 | 0 | — |
| +1 | K100071 | Emcoolspad | Emcools Emergency Medical Cooling Systems AG | 2010 | 6 | — |
| +1 | K101092 | Arctic Sun Temperature Management System, Model 5000 | Medivance, Inc. | 2010 | 8 | 3 |
| +1 | K071341 | Modification to Arctic Sun Temperature Management System, Model 2000 | Medivance, Inc. | 2007 | 20 | 1 |
| +1 | K012512 | Setpoint Endovascular Temperature Management System | Radiant Medical | 2002 | 27 | — |
| +2 | K240933 | CarbonCool® System | Global Healthcare SG Sdn. Bhd | 2025 | 0 | — |
| +2 | K231182 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System | Zoll Circulation, Inc. | 2023 | 1 | — |
| +2 | K180375 | The IQoolTM Warm System | Braincool AB | 2018 | 1 | — |
| +2 | K162523 | The IQool System | Braincool AB | 2017 | 2 | — |
| +2 | K161602 | Arctic Sun Temperature Management System | Medivance, Inc. | 2016 | 3 | 2 |
| +2 | K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and… | Medivance, Inc. | 2014 | 4 | 6 |
| +2 | K140078 | Tecotherm Neo (T Neo) | Inspiration Healthcare, Ltd. | 2014 | 0 | 1 |
| +2 | K121720 | Welkins Emt/Icu Temperature Managerment System | Welkins, LLC | 2012 | 0 | — |
| +2 | K100585 | Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900 | Gaymar Industries, Inc. | 2011 | 9 | — |
| +2 | K083662 | Criticool | Mtre Advanced Technology, Ltd. | 2009 | 16 | 1 |
| +2 | K071358 | Reprieve Endovascular Temperature Therapy System | Radiant Medical | 2007 | 0 | — |
| +2 | K063405 | Reprieve Endovascular Temperature Therapy System | Radiant Medical | 2007 | 1 | — |
| +2 | K033623 | Celsius Control System | Innercool Therapies, Inc. | 2004 | 2 | — |
| +2 | K030421 | Alsius Coolgard 3000 & Alsius Catheter System | Alsius Corp. | 2003 | 15 | 4 |
| +2 | K024327 | Setpoint Endovascular Temperature Probe | Radiant Medical | 2003 | 1 | — |
| +2 | K023914 | Coaxia Flocontrol Catheter | Coaxia, Inc. | 2003 | 6 | — |
| +2 | K022366 | Celsius Control System | Innercool Therapies | 2003 | 16 | — |
| +3 | K251974 | Arctic Sun Temperature Management System (Model 5000) | Medivance, Inc. | 2025 | 0 | — |
| +3 | K250979 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management… | Zoll Circulation, Inc. | 2025 | 0 | — |
| +3 | K232844 | The IQoolTM System | Braincool AB | 2023 | 0 | — |
| +3 | K200225 | Arctic Sun Stat Temperature Management System | Medivance, Inc. | 2020 | 1 | 1 |
| +3 | K152266 | Altrix Precision Temperature Management System | Stryker Medical | 2016 | 3 | 1 |
| +3 | K101589 | Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems | Cincinnati Sub-Zero Products, Inc. | 2010 | 4 | 6 |
| +3 | K090970 | Flocontrol , Model 1028 | Coaxia, Inc. | 2009 | 1 | — |
| +3 | K080908 | Innercool Therapies, Inc., Rapidblue System | Innercool Therapies, Inc.- A Delaware Corporation | 2008 | 1 | 1 |
| +3 | K080700 | Duoflo Catheter | Thermopeutix, Inc. | 2008 | 3 | — |
| +3 | K081936 | Solex Catheter, Model SL2593 | Alsius Corp. | 2008 | 5 | — |
| +3 | K052443 | Icy Catheter, Model IC-3893A | Alsius Corp. | 2005 | 8 | — |
| +3 | K051912 | Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A… | Alsius Corp. | 2005 | 0 | — |
| +3 | K042388 | Radiant Medical Endocatheter Temperature Probe | Radiant Medical | 2004 | 0 | — |
| +4 | K242964 | Celsi Warmer | Hadleigh Health Technologies | 2025 | 0 | — |
| +4 | K243942 | Arctic Sun Stat Temperature Management System | Medivance, Inc. | 2025 | 0 | — |
| +4 | K192786 | Gatekeeper Balloon Catheter | Arch Catheter, LLC | 2020 | 0 | — |
| +4 | K180834 | Altrix Precision Temperature Management System | Stryker Medical | 2018 | 0 | 1 |
| +4 | K171149 | Altrix Temperature Management Wraps | Stryker Medical | 2017 | 0 | — |
| +4 | K152946 | Tempedy | Seiratherm GmbH | 2016 | 0 | — |
| +4 | K141139 | Solex Intravascular Heat Exchange Catheter | Zoll Circulation | 2014 | 4 | — |
| +4 | K122813 | Hemotherm Model 400CE Cooler/Heater System | Cincinnati Sub-Zero Products, Inc. | 2012 | 0 | 6 |
| +4 | K120081 | Norm-O-Temp Hyperthermia System Incliding Blankets/Pads | Cincinnati Sub-Zero Products, Inc. | 2012 | 0 | 1 |
| +4 | K112219 | Tapas Catheter | Thermopeutix, Inc. | 2011 | 1 | — |
| +4 | K110104 | Blanketrol II Hyper-Hypothermia Temperature Managment System | Cincinnati Sub-Zero Products, Inc. | 2011 | 1 | 3 |
| +4 | K101987 | Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter… | Zoll Circulation | 2010 | 6 | — |
| +4 | K093847 | Duflo Catheter (Heparin Coated) | Thermopeutix, Inc. | 2010 | 0 | — |
| +4 | K070161 | Quattro Catheter Model IC4593 | Alsius Corp. | 2007 | 7 | — |
| +5 | K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | Zoll Circulation, Inc. | 2016 | 3 | 4 |
| +5 | K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular… | Zoll Circulation, Inc. | 2015 | 4 | 21 |
| +5 | K141175 | Renovocath RC120 | Renovorx, Inc. | 2014 | 0 | 1 |
| +6 | K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange… | Zoll Circulation, Inc. | 2021 | 2 | — |
| +7 | K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange… | Zoll Circulation, Inc. | 2023 | 0 | — |
| +7 | K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange… | Zoll Circulation, Inc. | 2022 | 1 | — |