# K071341: Modification to Arctic Sun Temperature Management System, Model 2000

- Pathway: 510(k) (Special)
- Applicant: Medivance, Inc.
- Decided: Aug 3, 2007 after 81 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: 1 generation back to K811742 (1981). 3 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 24 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.
- K912051: Medi-Therm (Mta-5900) & Detachable Hoses, Gaymar Industries, Inc. (1991) Summary page 1.
- K811742: Hemotherm Model 400, Cincinnati Sub-Zero (1981) Summary page 1.

## Most influential descendants
- K083662: Criticool (2009), 16 descendants of its own
- K100585: Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900 (2011), 9 descendants of its own
- K101092: Arctic Sun Temperature Management System, Model 5000 (2010), 8 descendants of its own
- 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
- K101589: Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems (2010), 4 descendants of its own

## Recalls of this device
- 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.

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

Source page: https://510kreport.com/device/K071341
Methodology: https://510kreport.com/methodology