510(k) Report

Devices descending from K942599

6 later devices reach Warm Air Warming Unit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101148Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc.201022
+1K101705Mistral-Air Warming SystemThe Surgical Company International B.V.201021
+2K171234Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company)20171—
+2K123946Warmair Model 135 Hyperthermia System Including Filteredflo BlanketsCincinnati Sub-Zero Products, Inc.20130—
+2K121669Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc.20121—
+3K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life20260—