# K991986: Cobe Brat 2 Autologous Blood Salvage System with the Crit-Line Hematocrit Sampling System Option

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Sep 9, 1999 after 87 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
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) COBE® BRAT® 2 Autologous Blood Salvage System: named in the summary without a submission number

## Most influential descendants
- K020647: Dideco Electa (2002), 7 descendants of its own
- K101586: Xtra Autotransfusion System (2010), 5 descendants of its own
- K112245: XTRA (2011), 1 descendant of its own
- K241236: XTRA Collection sets; XTRA Sequestration set X (2024), 0 descendants of its own
- K240584: XTRA Autotransfusion System (with XTRA Bowl sets) (2024), 0 descendants of its own

## Indications for use
The COBE BRAT 2 is indicated for use for the recovery and/or processing of autologous blood. The CRIT-LINE Hematocrit Sampling System option is used in conjunction with the BRAT 2 System to measure the hematocrit of the finished product in the reinfusion bag.

Source page: https://510kreport.com/device/K991986
Methodology: https://510kreport.com/methodology