# K972740: Himex Centriflow Centrifugal Perfusion Pump System (CFK01)

- Pathway: 510(k) (Traditional)
- Applicant: Himex Production Corp.
- Decided: Feb 6, 1998 after 199 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: 1 generation back to K920077 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920077: Nikkiso NK Pump, International Medical Products, Inc. (1993) Summary page 1.

## Most influential descendants
- K020571: Stockert Centrifugal Pump Console (2002), 0 descendants of its own

## Indications for use
The HIMEX Centriflow System is indicated for use in the maintenance of vital circulatory support as an extracorporeal circuit that is intended for use in cardiopulmonary bypass procedures less than six hours in duration.

Source page: https://510kreport.com/device/K972740
Methodology: https://510kreport.com/methodology