# K161602: Arctic Sun Temperature Management System

- Pathway: 510(k) (Special)
- Applicant: Medivance, Inc.
- Decided: Sep 2, 2016 after 85 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K912051 (1991). 13 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142702: Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad, Medivance, Inc. (2014) Summary page 4.
- K101092: Arctic Sun Temperature Management System, Model 5000, Medivance, Inc. (2010) Summary page 4.

## Most influential descendants
- K200225: Arctic Sun Stat Temperature Management System (2020), 1 descendant of its own
- K251974: Arctic Sun Temperature Management System (Model 5000) (2025), 0 descendants of its own
- K243942: Arctic Sun Stat Temperature Management System (2025), 0 descendants of its own

## Recalls of this device
- Jun 27, 2024 · Class II · Z-2457-2024: 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
- Jun 13, 2018 · Class II · Z-2536-2018: An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.

## Indications for use
The Arctic Sun® Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.

Source page: https://510kreport.com/device/K161602
Methodology: https://510kreport.com/methodology