# K984233: C.a.T.S Autotransfusion Accessories, Models Ats Suction Line, Aty Y-Adapter, and Ato Oxygenator Line

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Hemotechnology, Inc.
- Decided: Feb 1, 1999 after 68 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 K872159 (1987). 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)
- K872159: Dideco-Shiley Autotransfusion Accessories, Shiley, Inc. (1987) Summary page 1.

## Recalls of this device
- Jan 21, 2003 · Not classified · Z-0906-03: Sterility may be compromised

## Indications for use
The ATS Suction Line is a suction line to aspirate and anticoagulate blood from the surgical field into an autotransfusion reservoir with %4 suction port connected to a vacuum source. The ATY Y-Adapter is a Y-Adapter to connect two autotransfusion reservoirs with 1/4” female outlet connector to an autotransfusion device. The ATO Oxygenator Line is a tubing system to connect an oxygenator with 1/4” male connector to an autotransfusion device: - via a Y-adapter connected to an autotransfusion reservoir; or - directly to the autotransfusion device accepting a 1/4” female connector; or - via an autotransfusion reservoir.

Source page: https://510kreport.com/device/K984233
Methodology: https://510kreport.com/methodology