# K933625: Brat 2 Autologus Blood Salvage System

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Dec 29, 1993 after 163 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 6 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

## Recalls of this device
- Jun 22, 2005 · Not classified · Z-1072-05: Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
- Jun 22, 2005 · Not classified · Z-1070-05: Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
- Jun 22, 2005 · Not classified · Z-1069-05: Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
- Jun 22, 2005 · Not classified · Z-1071-05: Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
- Jun 22, 2005 · Not classified · Z-1073-05: Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
- Jun 22, 2005 · Not classified · Z-1074-05: Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.

Source page: https://510kreport.com/device/K933625
Methodology: https://510kreport.com/methodology