# K243942: Arctic Sun Stat Temperature Management System

- Pathway: 510(k) (Traditional)
- Applicant: Medivance, Inc.
- Decided: Apr 30, 2025 after 131 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K912051 (1991). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200225: Arctic Sun Stat Temperature Management System, Medivance, Inc. (2020) Summary page 5.

## 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/K243942
Methodology: https://510kreport.com/methodology