# K051303: Bio-Console, Model 560

- Pathway: 510(k) (Special)
- Applicant: Medtronic Perfusion Systems
- Decided: Jun 10, 2005 after 22 days
- Product code: DWA (Control, Pump Speed, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4380
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924205 (1993). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924205: Medtronic Bio-Medicus Bio-Console Model 550, Medtronic Bio-Medicus, Inc. (1993) Summary page 1.
- K936091: Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller, Medtronic Bio-Medicus, Inc. (1994) Summary page 1.

## Most influential descendants
- K070286: Bio-Console, Model 560 (2007), 6 descendants of its own
- K080824: Bio-Console 560 (2008), 3 descendants of its own
- K131964: Bio-Console 560 Extracorporeal Blood Pumping Console (2013), 2 descendants of its own
- K221491: Anivia SG1000 Pump Console (2023), 1 descendant of its own
- K230698: Anivia SG1000 Pump Console (2023), 0 descendants of its own

## Recalls of this device
- Apr 21, 2010 · Not classified · Z-1939-2010: The potential risks during the use of this power cord include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Although Medtronic has received no repor

## Indications for use
The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).

Source page: https://510kreport.com/device/K051303
Methodology: https://510kreport.com/methodology