# K973011: BPX80 Bio-Pump (BPX80)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Bio-Medicus, Inc.
- Decided: Feb 25, 1998 after 196 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K852698 (1985). 3 ancestors in all.
48 later devices descend from it; 10 cite it directly.
4 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852698: Bio Medicus Bio Pump Model BP-80, Bio Medicus, Inc. (1985) Summary page 1.
- K891687: Extracorporeal Circuit with Bio-Active Surface, Medtronic Blood Systems, Inc. (1989) Summary page 1.
- K896978: Closed Chest Support Circuit W/Bio-Active Surface, Medtronic Vascular (1990) Summary page 1.

## Most influential descendants
- K020271: Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 (2003), 21 descendants of its own
- K991783: AB-180 XC System, Model AB-180XC (2000), 13 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
- K100631: Affiity CP Centrifugal Blood Pump (2010), 9 descendants of its own

## Indications for use
The Medtronic Bio-Medicus Bio-Pump centrifugal blood pump is indicated for use only with the Medtronic Bio-Medicus Bio-Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

Source page: https://510kreport.com/device/K973011
Methodology: https://510kreport.com/methodology