# K131553: XTRA

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Mar 21, 2014 after 295 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: 5 generations back to K884564 (1989). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112245: XTRA, Sorin Group Italia S.R.L. (2011) Summary page 1.

## Indications for use
The XTRA Autotransfusion System is indicated for intreoperative 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/K131553
Methodology: https://510kreport.com/methodology