510(k) Report

Devices descending from K101589

4 later devices reach Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122813Hemotherm Model 400CE Cooler/Heater SystemCincinnati Sub-Zero Products, Inc.201206
+1K120081Norm-O-Temp Hyperthermia System Incliding Blankets/PadsCincinnati Sub-Zero Products, Inc.201201
+1K110104Blanketrol II Hyper-Hypothermia Temperature Managment SystemCincinnati Sub-Zero Products, Inc.201113
+2K121720Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC20120—