# K974897: Cobe Brat 2 System with Modified Standard Volume Processing Set

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Mar 31, 1998 after 90 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933960 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933625: Brat 2 Autologus Blood Salvage System, Cobe Cardiovascular, Inc. (1993) Summary page 2.
- K962689: Cobe Brat 2 Autologous Blood Salvage System with Modified Plasma Recovery Program (PRP), Cobe Cardiovascular, Inc. (1997) Summary page 2.

## Indications for use
The COBE BRAT 2 is indicated for use for recovery and/or processing of autologous blood.

Source page: https://510kreport.com/device/K974897
Methodology: https://510kreport.com/methodology