# K963759: Dideco Compact-a and Compact-M Autotransfusion Systems

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Biomedical, Inc.
- Decided: Feb 20, 1998 after 520 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.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Electromedics AT-1000: named in the summary without a submission number

## 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
- K012406: Access Sequestration System (2002), 1 descendant of its own

## Indications for use
The Compact-A and Compact-M Autotransfusion Systems are intended to process, shed or collect blood for autologuous transfusion. The Compact-A and Compact-M autotransfusion systems are to be used with disposables for the collection of shed blood and aspirated body fluids and the separation of erythrocytes from other components of the aspirated blood prior to, during and/or after a surgical procedure. The systems are also recommended to collect platelet-rich plasma (PRP) and/or platelet-poor plasma (PPP) from the patient's whole blood immediately preoperative to a surgical procedure.

Source page: https://510kreport.com/device/K963759
Methodology: https://510kreport.com/methodology