# K103202: Preassembled Surgical Wash Set

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Nov 23, 2010 after 22 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). 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)
- K872161: Dideco-Shiley Preassembled Surgical Wash Set, Shiley, Inc. (1987) Summary page 1.
- K020647: Dideco Electa, Dideco S.P.A. (2002) Summary page 1.
- K982650: Autologous Blood Management System (Abms), Dideco S.P.A. (1998) Summary page 1.
- K101586: Xtra Autotransfusion System, Sorin Group Italia S.R.L. (2010) Summary page 1.

## Indications for use
The Preassembled Surgical Wash Set is intended for use with specific Autotransfusion machines which are identified on the primary label. It contains the basic components necessary to process blood collected during open heart or other surgical procedures for autotransfusion.

Source page: https://510kreport.com/device/K103202
Methodology: https://510kreport.com/methodology