# K915363: Sarns 7850 Centrifugal Pump (Modified)

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Ltd.
- Decided: Jul 28, 1993 after 609 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020998: Sarns Centrifugal Pump with Xcoating, Model 164275X (2002), 3 descendants of its own
- 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
- K952879: Sarns Centrifugal Pump with Duraflo II Treatment (1996), 0 descendants of its own

## Recalls of this device
- Jul 6, 2009 · Not classified · Z-0545-2010: The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.

Source page: https://510kreport.com/device/K915363
Methodology: https://510kreport.com/methodology