# K020529: Large Centrifugal Blood Pump, Model CP-2

- Pathway: 510(k) (Traditional)
- Applicant: A-Med Systems, Inc.
- Decided: Aug 26, 2002 after 188 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: 3 generations back to K852698 (1985). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992592: A-Miniature Centrifugal Blood Pump System, Model CPB 2000, A-Med Systems, Inc. (2000) Summary page 1.
- K973011: BPX80 Bio-Pump (BPX80), Medtronic Bio-Medicus, Inc. (1998) Summary page 1.

## Indications for use
The A-Med Large Centrifugal Blood Pump is indicated for pumping 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 operations, surgery of the vena cava or aorta, liver transplants, etc). The A-Med Large Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.

Source page: https://510kreport.com/device/K020529
Methodology: https://510kreport.com/methodology