# K982650: Autologous Blood Management System (Abms)

- Pathway: 510(k) (Abbreviated)
- Applicant: Dideco S.P.A.
- Decided: Dec 16, 1998 after 139 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: 1 generation back to K884564 (1989). 5 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884564: Shiley Therapeutic Autotransfusion System-Programm, Shiley, Inc. (1989) Summary page 2.
- K910991: Shiley Therapeutic Autotransfusion System, Shiley, Inc. (1991) Summary page 2.
- K940519: Dideco Compact-a Autotransfusion System, Dideco (1995) Summary page 2.
- K963758: Code 150 Blood Component Collection Set and with Direct Draw Line, Sorin Biomedical, Inc. (1998) Summary page 2.
- K963759: Dideco Compact-a and Compact-M Autotransfusion Systems, Sorin Biomedical, Inc. (1998) Summary page 2.
- (no number) AT-1000: named in the summary without a submission number

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

## Recalls of this device
- Aug 4, 2006 · Not classified · Z-1490-06: 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-1488-06: 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 ABMS is indicated for intraoperative recovery of blood, washing of blood collected in the post-operative period, and pre-operative 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/K982650
Methodology: https://510kreport.com/methodology