510(k) Report

Devices descending from K061023

18 later devices reach Thermosuit System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100071EmcoolspadEmcools Emergency Medical Cooling Systems AG20106—
+1K070112Rapidcool Patient Temperature Management SystemMedcool, Inc.200711—
+2K240933CarbonCool® SystemGlobal Healthcare SG Sdn. Bhd20250—
+2K231182Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemZoll Circulation, Inc.20231—
+2K162523The IQool SystemBraincool AB20172—
+2K121720Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC20120—
+2K120849Hybrid Arcticgel PadMedivance, Inc.20120—
+2K100585Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc.20119—
+3K250979Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management…Zoll Circulation, Inc.20250—
+3K152266Altrix Precision Temperature Management SystemStryker Medical201631
+3K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Medivance, Inc.201446
+4K242964Celsi WarmerHadleigh Health Technologies20250—
+4K180834Altrix Precision Temperature Management SystemStryker Medical201801
+4K171149Altrix Temperature Management WrapsStryker Medical20170—
+4K161602Arctic Sun Temperature Management SystemMedivance, Inc.201632
+5K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.20250—
+5K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc.202011
+6K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.20250—