510(k) Report

Devices descending from K003349

36 later devices reach Allon 2001 Modified through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100585Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc.20119—
+1K040440HTTP System (HTTP 2001 Controller and HTTP Warm ME Blankets)Http Hypothermia Therapy20040—
+1K024128Allon 2001 Version 5Mtre Advanced Technology, Ltd.2003171
+1K022366Celsius Control SystemInnercool Therapies200316—
+2K152266Altrix Precision Temperature Management SystemStryker Medical201631
+2K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Medivance, Inc.201446
+2K140078Tecotherm Neo (T Neo)Inspiration Healthcare, Ltd.201401
+2K083662CriticoolMtre Advanced Technology, Ltd.2009161
+2K071358Reprieve Endovascular Temperature Therapy SystemRadiant Medical20070—
+2K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp.2003154
+3K242964Celsi WarmerHadleigh Health Technologies20250—
+3K180834Altrix Precision Temperature Management SystemStryker Medical201801
+3K171149Altrix Temperature Management WrapsStryker Medical20170—
+3K161602Arctic Sun Temperature Management SystemMedivance, Inc.201632
+3K101589Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsCincinnati Sub-Zero Products, Inc.201046
+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—
+3K033623Celsius Control SystemInnercool Therapies, Inc.20042—
+4K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.20250—
+4K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc.202011
+4K141139Solex Intravascular Heat Exchange CatheterZoll Circulation20144—
+4K122813Hemotherm Model 400CE Cooler/Heater SystemCincinnati Sub-Zero Products, Inc.201206
+4K120081Norm-O-Temp Hyperthermia System Incliding Blankets/PadsCincinnati Sub-Zero Products, Inc.201201
+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—
+4K080908Innercool Therapies, Inc., Rapidblue SystemInnercool Therapies, Inc.- A Delaware Corporation200811
+4K070161Quattro Catheter Model IC4593Alsius Corp.20077—
+5K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.20250—
+5K152946TempedySeiratherm GmbH20160—
+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
+5K121720Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC20120—
+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—