# K120849: Hybrid Arcticgel Pad

- Pathway: 510(k) (Traditional)
- Applicant: Medivance, Inc.
- Decided: Jul 20, 2012 after 122 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: 3 generations back to K912051 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K100071: Emcoolspad, Emcools Emergency Medical Cooling Systems AG (2010) Summary page 1.

## Indications for use
The Hybrid ArcticGel Pad is indicated as a standalone cooling device for the reduction of core temperature of adult patients where clinically indicated (e.g. heat stroke or hyperthermia). Additionally, the Hybrid ArcticGel Pad is indicated as an adjunct to patient temperature control with the Arctic Sun® Temperature Management System. The Hybrid ArcticGel Pad is intended for use by health care professionals in all clinical environments, including, but not limited to in-hospital as well as EMS/transport settings.

Source page: https://510kreport.com/device/K120849
Methodology: https://510kreport.com/methodology