# K010338: Artic Sun Temperature Management System, Model 200

- Pathway: 510(k) (Special)
- Applicant: Medivance, Inc.
- Decided: Mar 7, 2001 after 30 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
No predicates in its family tree.
55 later devices descend from it; 5 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012512: Setpoint Endovascular Temperature Management System (2002), 27 descendants of its own
- K071341: Modification to Arctic Sun Temperature Management System, Model 2000 (2007), 20 descendants of its own
- K083662: Criticool (2009), 16 descendants of its own
- K022366: Celsius Control System (2003), 16 descendants of its own
- K030421: Alsius Coolgard 3000 & Alsius Catheter System (2003), 15 descendants of its own

## Recalls of this device
- Jan 5, 2005 · Not classified · Z-0436-05: Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.

Source page: https://510kreport.com/device/K010338
Methodology: https://510kreport.com/methodology