# K200225: Arctic Sun Stat Temperature Management System

- Pathway: 510(k) (Special)
- Applicant: Medivance, Inc.
- Decided: Feb 28, 2020 after 29 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K912051 (1991). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161602: Arctic Sun Temperature Management System, Medivance, Inc. (2016) Summary page 4.

## Most influential descendants
- 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

## 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/K200225
Methodology: https://510kreport.com/methodology