# K112245: XTRA

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Sep 6, 2011 after 33 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.
1 later device descends from it; 1 cites it directly.
0 of 11 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 1.

## Most influential descendants
- K131553: XTRA (2014), 0 descendants of its own

## Indications for use
The XTRA Autotransfusion System 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 include the following surgical specialties: *Cardiovascular *Orthopedics *Thoracic *Transplant Surgery *Emergency (Trauma) *Neurosurgery *Obstetrics and gynecology *Urology

Source page: https://510kreport.com/device/K112245
Methodology: https://510kreport.com/methodology