# K100631: Affiity CP Centrifugal Blood Pump

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Jun 22, 2010 after 109 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: 2 generations back to K852698 (1985). 6 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973011: BPX80 Bio-Pump (BPX80), Medtronic Bio-Medicus, Inc. (1998) Summary page 1.
- K936091: Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller, Medtronic Bio-Medicus, Inc. (1994) Summary page 1.
- K926357: Medtronic Bio-Medicus Handcrank Model 150, Medtronic Bio-Medicus, Inc. (1993) Summary page 1.

## Most influential descendants
- K111658: Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive Surface (2011), 7 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
- K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right (2012), 4 descendants of its own
- K140165: MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, MC2X Three-Stage VE (2014), 2 descendants of its own
- K251258: MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (2025), 1 descendant of its own

## Indications for use
The AFFINJTYTM 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.

Source page: https://510kreport.com/device/K100631
Methodology: https://510kreport.com/methodology