510(k) Report

Devices descending from K100585

9 later devices reach Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152266Altrix Precision Temperature Management SystemStryker Medical201631
+1K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Medivance, Inc.201446
+2K242964Celsi WarmerHadleigh Health Technologies20250—
+2K180834Altrix Precision Temperature Management SystemStryker Medical201801
+2K171149Altrix Temperature Management WrapsStryker Medical20170—
+2K161602Arctic Sun Temperature Management SystemMedivance, Inc.201632
+3K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.20250—
+3K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc.202011
+4K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.20250—