510(k) Report

Devices descending from K101092

8 later devices reach Arctic Sun Temperature Management System, Model 5000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180375The IQoolTM Warm SystemBraincool AB20181—
+1K161602Arctic Sun Temperature Management SystemMedivance, Inc.201632
+1K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Medivance, Inc.201446
+1K121720Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC20120—
+2K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.20250—
+2K232844The IQoolTM SystemBraincool AB20230—
+2K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc.202011
+3K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.20250—