# K180831: CATSmart

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Kabi AG
- Decided: Dec 10, 2018 after 255 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971274 (1997). 1 ancestor in all.
2 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)
- K971274: C.a.T.S Continuous Autotransfusion System, AT1 Autotransfusion Set, PSQ Set, Fresenius AG (1997) Summary page 4.

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

## Recalls of this device
- Feb 11, 2019 · Class II · Z-1059-2019: The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.

## Indications for use
The CATSmart System by Fresenius Kabi 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/K180831
Methodology: https://510kreport.com/methodology