# K131964: Bio-Console 560 Extracorporeal Blood Pumping Console

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jul 24, 2013 after 27 days
- Product code: DWA (Control, Pump Speed, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4380
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K915183 (1992). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080824: Bio-Console 560, Medtronic Perfusion Systems (2008) Summary page 1.

## Most influential descendants
- 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
- Mar 3, 2021 · Class I · Z-1313-2021: An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopp

## 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/K131964
Methodology: https://510kreport.com/methodology