# K153162: Hypocore

- Pathway: 510(k) (Traditional)
- Applicant: Novocor Medical Systems, Inc.
- Decided: May 24, 2016 after 204 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
Longest line of descent: 1 generation back to K080899 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080899: Arctic Blast Intravenous Fluid Chiller, Medivance, Inc. (2008) Summary page 4.

## Indications for use
Hypocore™ is a single-use device intended to cool sterile saline, lactated ringers and other comparable low viscosity inert fluids during intravenous administration where clinically indicated for reduction of patient temperature.

Source page: https://510kreport.com/device/K153162
Methodology: https://510kreport.com/methodology