# K080899: Arctic Blast Intravenous Fluid Chiller

- Pathway: 510(k) (Traditional)
- Applicant: Medivance, Inc.
- Decided: Aug 7, 2008 after 129 days
- Product code: NCX (System, Hypothermia, Intravenous, Cooling)
- 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) IVFluid Cooler / Warmer: named in the summary without a submission number
- (no number) System 1025 Fast Flow Blood and Fluid Warmer: named in the summary without a submission number
- (no number) Celsius Control System: named in the summary without a submission number
- (no number) Thermosuit: named in the summary without a submission number

## Most influential descendants
- K152946: Tempedy (2016), 0 descendants of its own
- K153162: Hypocore (2016), 0 descendants of its own

## Indications for use
The Arctic Blast® Intravenous Fluid Chiller is intended to cool sterile solutions during intravenous administration where clinically indicated for reduction of patient temperature.

Source page: https://510kreport.com/device/K080899
Methodology: https://510kreport.com/methodology