# K962689: Cobe Brat 2 Autologous Blood Salvage System with Modified Plasma Recovery Program (PRP)

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Jan 28, 1997 after 201 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: 1 generation back to K933960 (1994). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933960: Plasma Recovery Program for the Cobe Brat 2 Autologous Blood Salvage System, Cobe Cardiovascular, Inc. (1994) Summary page 1.
- (no number) Electromedics Autotransfusion Machine AT 500: named in the summary without a submission number

## Most influential descendants
- K974897: Cobe Brat 2 System with Modified Standard Volume Processing Set (1998), 0 descendants of its own
- K973627: Standard Volume Processing Set for the Cobe Brat 2 Autologous Blood Salvage System (1997), 0 descendants of its own

## 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/K962689
Methodology: https://510kreport.com/methodology