510(k) Report

Devices descending from K070112

11 later devices reach Rapidcool Patient Temperature Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121720Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC20120—
+1K100585Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc.20119—
+2K152266Altrix Precision Temperature Management SystemStryker Medical201631
+2K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Medivance, Inc.201446
+3K242964Celsi WarmerHadleigh Health Technologies20250—
+3K180834Altrix Precision Temperature Management SystemStryker Medical201801
+3K171149Altrix Temperature Management WrapsStryker Medical20170—
+3K161602Arctic Sun Temperature Management SystemMedivance, Inc.201632
+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—