# K132712: Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Nov 19, 2013 after 82 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: 4 generations back to K852698 (1985). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100631: Affiity CP Centrifugal Blood Pump, Medtronic, Inc. (2010) Summary page 1.
- K111657: Affinity CP Centrifugal Blood Pump with Balance Biosurface, Medtronic, Inc. (2011) Summary page 1.
- K111658: Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive Surface, Medtronic, Inc. (2011) Summary page 1.
- K112229: Sarn Centrifugal Pump, Terumo Cardiovascular Systems (2011) Summary page 1.

## Indications for use
The Affinity CP Centrifugal Blood Pump is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours). It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants). The Affinity CP Centrifugal Blood Pump is driven by the External Drive Motor or the Emergency Handcrank. The Affinity CP Centrifugal Blood Pump is intended for use with Medtronic controllers or may be used with the Stockert and Sorin centrifugal pump systems or the Sarns and Terumo centrifugal systems by attaching the Affinity CP adapter.

Source page: https://510kreport.com/device/K132712
Methodology: https://510kreport.com/methodology