510(k) Report

Devices descending from K071341

20 later devices reach Modification to Arctic Sun Temperature Management System, Model 2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140078Tecotherm Neo (T Neo)Inspiration Healthcare, Ltd.201401
+1K100585Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc.20119—
+1K101092Arctic Sun Temperature Management System, Model 5000Medivance, Inc.201083
+1K083662CriticoolMtre Advanced Technology, Ltd.2009161
+2K180375The IQoolTM Warm SystemBraincool AB20181—
+2K152266Altrix Precision Temperature Management SystemStryker Medical201631
+2K161602Arctic Sun Temperature Management SystemMedivance, Inc.201632
+2K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Medivance, Inc.201446
+2K121720Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC20120—
+2K101589Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsCincinnati Sub-Zero Products, Inc.201046
+3K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.20250—
+3K242964Celsi WarmerHadleigh Health Technologies20250—
+3K232844The IQoolTM SystemBraincool AB20230—
+3K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc.202011
+3K180834Altrix Precision Temperature Management SystemStryker Medical201801
+3K171149Altrix Temperature Management WrapsStryker Medical20170—
+3K122813Hemotherm Model 400CE Cooler/Heater SystemCincinnati Sub-Zero Products, Inc.201206
+3K120081Norm-O-Temp Hyperthermia System Incliding Blankets/PadsCincinnati Sub-Zero Products, Inc.201201
+3K110104Blanketrol II Hyper-Hypothermia Temperature Managment SystemCincinnati Sub-Zero Products, Inc.201113
+4K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.20250—