# K101092: Arctic Sun Temperature Management System, Model 5000

- Pathway: 510(k) (Traditional)
- Applicant: Medivance, Inc.
- Decided: Jul 16, 2010 after 87 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K811742 (1981). 4 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010338: Artic Sun Temperature Management System, Model 200, Medivance, Inc. (2001) Summary page 1.
- K071341: Modification to Arctic Sun Temperature Management System, Model 2000, Medivance, Inc. (2007) Summary page 1.

## Most influential descendants
- K142702: Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad (2014), 4 descendants of its own
- K161602: Arctic Sun Temperature Management System (2016), 3 descendants of its own
- K200225: Arctic Sun Stat Temperature Management System (2020), 1 descendant of its own
- K180375: The IQoolTM Warm System (2018), 1 descendant of its own
- K251974: Arctic Sun Temperature Management System (Model 5000) (2025), 0 descendants of its own

## Recalls of this device
- Mar 31, 2017 · Class II · Z-3042-2017: Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.
- Nov 10, 2015 · Class II · Z-0760-2016: Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.
- Nov 9, 2015 · Class II · Z-1617-2016: The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Me

## Indications for use
The Arctic Sun Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature.

Source page: https://510kreport.com/device/K101092
Methodology: https://510kreport.com/methodology