# K941921: Bio-Medicus Bio-Console Models 540, 540A,B,C,D,E, & 550

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Bio-Medicus, Inc.
- Decided: Jul 20, 1994 after 91 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
No predicates in its family tree.
22 later devices descend from it; 1 cites it directly.
4 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020271: Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 (2003), 21 descendants of its own
- K053630: Levitronix Centrimag Primary Console (2006), 11 descendants of its own
- K081221: Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console (2008), 10 descendants of its own
- K083340: Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console (2008), 9 descendants of its own
- K102129: Levitronix 2ND Generation Centrimag Primary Console, Levitronix Monitor (2010), 4 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

Source page: https://510kreport.com/device/K941921
Methodology: https://510kreport.com/methodology