# K020647: Dideco Electa

- Pathway: 510(k) (Abbreviated)
- Applicant: Dideco S.P.A.
- Decided: Sep 5, 2002 after 189 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K884564 (1989). 7 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982650: Autologous Blood Management System (Abms), Dideco S.P.A. (1998) Summary page 1.
- K991986: Cobe Brat 2 Autologous Blood Salvage System with the Crit-Line Hematocrit Sampling System Option, Cobe Cardiovascular, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K240584: XTRA Autotransfusion System (with XTRA Bowl sets) (2024), 0 descendants of its own
- K131553: XTRA (2014), 0 descendants of its own

## Recalls of this device
- Aug 4, 2006 · Not classified · Z-1491-06: Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
- Aug 4, 2006 · Not classified · Z-1489-06: Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.

## Indications for use
The Dideco electa is indicated for intraoperative recovery of blood, washng of blood collected in the post-operative period, and preKoperative sequestration (with indirect and direct 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/K020647
Methodology: https://510kreport.com/methodology