# K020998: Sarns Centrifugal Pump with Xcoating, Model 164275X

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Apr 4, 2002 after 7 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915363 (1993). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915363: Sarns 7850 Centrifugal Pump (Modified), 3M Health Care, Ltd. (1993) Summary page 1.

## Most influential descendants
- K112229: Sarn Centrifugal Pump (2011), 1 descendant of its own
- K132712: Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP Adapter (2013), 0 descendants of its own
- K082321: Terumo Rocsafe Hybrid Perfusion System (2009), 0 descendants of its own

## Recalls of this device
- Mar 15, 2010 · Not classified · Z-2606-2010: Medical device component may malfunction and require user intervention during surgical bypass procedures.
- Jul 6, 2009 · Not classified · Z-0544-2010: The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.

## Indications for use
The Sarns ™ Centrifugal Pump with X-Coating is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures only, and for use exclusively with Sarns centrifugal control systems. The device may be used for up to 6 hours.

Source page: https://510kreport.com/device/K020998
Methodology: https://510kreport.com/methodology