# K101586: Xtra Autotransfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Oct 5, 2010 after 120 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: 3 generations back to K884564 (1989). 8 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020647: Dideco Electa, Dideco S.P.A. (2002) Summary page 1.

## Most influential descendants
- K112245: XTRA (2011), 1 descendant of its own
- K241236: XTRA Collection sets; XTRA Sequestration set X (2024), 0 descendants of its own
- K240584: XTRA Autotransfusion System (with XTRA Bowl sets) (2024), 0 descendants of its own
- K131553: XTRA (2014), 0 descendants of its own
- K103202: Preassembled Surgical Wash Set (2010), 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 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/K101586
Methodology: https://510kreport.com/methodology