# K971274: C.a.T.S Continuous Autotransfusion System, AT1 Autotransfusion Set, PSQ Set

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius AG
- Decided: Jun 13, 1997 after 67 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.
3 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic Sequestra 1000: named in the summary without a submission number
- (no number) Haemonetics’s CellSaver 5 Autotransfusion Systems: named in the summary without a submission number

## Most influential descendants
- K180831: CATSmart (2018), 2 descendants of its own
- K192368: CATSmart (2019), 1 descendant of its own
- K210089: CATSmart, Automated Blood Processing Autotransfusion System (2021), 0 descendants of its own

## Indications for use
The C.A.T.S (Continuous Autotransfusion System) by Fresenius is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Rich Plasma (PRP).

Source page: https://510kreport.com/device/K971274
Methodology: https://510kreport.com/methodology