# K884564: Shiley Therapeutic Autotransfusion System-Programm

- Pathway: 510(k) (Traditional)
- Applicant: Shiley, Inc.
- Decided: May 5, 1989 after 185 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982650: Autologous Blood Management System (Abms) (1998), 8 descendants of its own
- K020647: Dideco Electa (2002), 7 descendants of its own
- K101586: Xtra Autotransfusion System (2010), 5 descendants of its own
- K112245: XTRA (2011), 1 descendant of its own
- K241236: XTRA Collection sets; XTRA Sequestration set X (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K884564
Methodology: https://510kreport.com/methodology