# K110782: XVAC

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Apr 7, 2011 after 17 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: 1 generation back to K936220 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936220: Dideco Vacuum Pump, Dideco (1995) Summary page 1.

## Indications for use
The XVAC is intended for use in autotransfusion, for the aspiration of shed blood (which is subsequently processed and reinfused to the patient) in the operating room or patient care areas.

Source page: https://510kreport.com/device/K110782
Methodology: https://510kreport.com/methodology