# K240584: XTRA Autotransfusion System (with XTRA Bowl sets)

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Apr 29, 2024 after 59 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: 4 generations back to K884564 (1989). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101586: Xtra Autotransfusion System, Sorin Group Italia S.R.L. (2010) Summary page 5.

## Indications for use
The XTRA Autotransfusion System (including the XTRA bowl set) is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative period, and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: - Cardiovascular - Orthopedics - Thoracic - Transplant Surgery - Emergency (Trauma) - Neurosurgery - Obstetrics and gynecology - Urology

Source page: https://510kreport.com/device/K240584
Methodology: https://510kreport.com/methodology