# K112229: Sarn Centrifugal Pump

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems
- Decided: Dec 9, 2011 after 128 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915363 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020998: Sarns Centrifugal Pump with Xcoating, Model 164275X, Terumo Cardiovascular Systems Corp. (2002) Summary page 1.
- K915363: Sarns 7850 Centrifugal Pump (Modified), 3M Health Care, Ltd. (1993) 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

## Recalls of this device
- May 27, 2015 · Class II · Z-1235-2017: Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the
- Apr 14, 2014 · Class II · Z-2029-2014: During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
- Apr 14, 2014 · Class II · Z-2028-2014: During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
- Apr 14, 2014 · Class II · Z-2030-2014: During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.

## Indications for use
The Sarns® Centrifugal Pump with or without X-CoatingTM is a sterile, single use device, used as an extracorporeal blood pump for use in cardiopulmonary bypass procedures for up to 6 hours. The pump is intended for use with the Sarns@ Centrifugal Systems or may be used with Stockert Centrifugal Pump Systems by attaching the Sarns® Centrifugal Pump Adapter.

Source page: https://510kreport.com/device/K112229
Methodology: https://510kreport.com/methodology