510(k) Report

Devices descending from K083662

16 later devices reach Criticool 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—
+1K101589Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsCincinnati Sub-Zero Products, Inc.201046
+2K152266Altrix Precision Temperature Management SystemStryker Medical201631
+2K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Medivance, Inc.201446
+2K122813Hemotherm Model 400CE Cooler/Heater SystemCincinnati Sub-Zero Products, Inc.201206
+2K120081Norm-O-Temp Hyperthermia System Incliding Blankets/PadsCincinnati Sub-Zero Products, Inc.201201
+2K110104Blanketrol II Hyper-Hypothermia Temperature Managment SystemCincinnati Sub-Zero Products, Inc.201113
+3K242964Celsi WarmerHadleigh Health Technologies20250—
+3K180834Altrix Precision Temperature Management SystemStryker Medical201801
+3K171149Altrix Temperature Management WrapsStryker Medical20170—
+3K161602Arctic Sun Temperature Management SystemMedivance, Inc.201632
+3K121720Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC20120—
+4K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.20250—
+4K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc.202011
+5K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.20250—