# K241236: XTRA Collection sets; XTRA Sequestration set X

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Aug 16, 2024 after 106 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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 6.
- K131103: Xres Blood Collection Reservoir Xres 120MICROMETER Blood Collection Reservoir, Sorin Group Italia S.R.L. (2013) Summary page 6.

## Indications for use
For XTRA Collection sets: "The XTRA Autotransufion System (including the XTRA Collection sets) 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" For XTRA Sequestration set X: "The XTRA Autotransufion System (including the XTRA Sequestration set X) 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/K241236
Methodology: https://510kreport.com/methodology