# K964673: Bair Hugger Model 630 Cardiac Blanket

- Pathway: 510(k) (Traditional)
- Applicant: Augustine Medical, Inc.
- Decided: Jun 26, 1997 after 217 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: 1 generation back to K903360 (1990). 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)
- K903360: Bair Hugger (R) Patient Warming System-Modification, Augustine Medical, Inc. (1990) Summary page 1.

## Indications for use
The Bair Hugger® Model 630 Cardiac Blanket is intended to be used to warm adult patients during cardiac surgery.

Source page: https://510kreport.com/device/K964673
Methodology: https://510kreport.com/methodology