# K160735: CATSmart

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Kabi AG
- Decided: Sep 16, 2016 after 183 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 K960006 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960006: C.a.T.S. Continuous Autotransfusion System, Fresenius AG (1996) Summary page 4.

## Recalls of this device
- Mar 5, 2019 · Class II · Z-1209-2019: Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events involving the CATSmart Systems, including the device, software, and disposable which may result in the cent

## Indications for use
The CATSmart (Continuous Autotransfusion System) device 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.

Source page: https://510kreport.com/device/K160735
Methodology: https://510kreport.com/methodology