# K192368: CATSmart

- Pathway: 510(k) (Special)
- Applicant: Fresenius Kabi AG
- Decided: Sep 27, 2019 after 28 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: 2 generations back to K971274 (1997). 2 ancestors in all.
1 later device descends 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)
- K180831: CATSmart, Fresenius Kabi AG (2018) Summary page 5.

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

## 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/K192368
Methodology: https://510kreport.com/methodology