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Medivance, Inc.

Last updated September 17, 2026

Information

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Device	Model / Reference	Registries	Class	Status
Arctic Sun Stat Temperature Management System	K200225	FDA 510(k)	Class II	Active
Arctic Sun Temperature Management System, Model 5000	K101092	FDA 510(k)	Class II	Active
Hybrid Arcticgel Pad	K120849	FDA 510(k)	Class II	Active
Artic Sun Temperature Management System, Model 200	K010338	FDA 510(k)	Class II	Active
Arctic Blast Intravenous Fluid Chiller	K080899	FDA 510(k)	Class II	Active
Arctic Sun Temperature Management System, Model 100 Control Unit And Patient Energy Transfer Pads	K002577	FDA 510(k)	Class II	Active
Modification To Arctic Sun Temperature Management System, Model 2000	K071341	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 27, 2024	Z-2457-2024	—	open, classified	If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.
Feb 16, 2024	Z-1381-2024	—	open, classified	Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.
Jan 5, 2005	Z-0436-05	—	terminated	Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.