# K936091: Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Bio-Medicus, Inc.
- Decided: Dec 23, 1994 after 366 days
- Product code: DWA (Control, Pump Speed, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 3 cite it directly.
1 of 21 devices in its family (counting itself) has 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
- K100631: Affiity CP Centrifugal Blood Pump (2010), 9 descendants of its own
- K111658: Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive Surface (2011), 7 descendants of its own
- K051303: Bio-Console, Model 560 (2005), 7 descendants of its own
- K070286: Bio-Console, Model 560 (2007), 6 descendants of its own
- K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf (2011), 5 descendants of its own

Source page: https://510kreport.com/device/K936091
Methodology: https://510kreport.com/methodology