# K111657: Affinity CP Centrifugal Blood Pump with Balance Biosurface

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jun 23, 2011 after 9 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.
1 later device descends from it; 1 cites it directly.
0 of 10 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.
- K100646: Affinity Pixie Arterial Filter with Balance Biosurface, Medtronic, Inc. (2010) Summary page 1.

## Most influential descendants
- K132712: Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP Adapter (2013), 0 descendants of its own

## Indications for use
The Affinity'TM CF CentrifugalBlood Pumtp with BalanceTM Biosurface is used to pump blood through the extracorporealbypass circuitfor extracorporealcirculalty supportfor periods appropriateto cardiopulmonarybypass (up to 6 hours). It/is also indicatedfor use in extracorporealsupport systems (forperiods up to 6 hours) not requiringcomplete cardiopulmonarybypass (e.g. valvuloplasty, circulatory support during mnitral valve reoperation,surgery of the vena cava or aorta, liver transplants). The AffinityTM CF CentrifugalBlood Pump with BalanceTm Biosurface is driven by the External Drive Motor or the Emtergency Handcrank

Source page: https://510kreport.com/device/K111657
Methodology: https://510kreport.com/methodology