# K200091: Capiox iCP Centrifugal Pump

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: Nov 18, 2021 after 672 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Capiox® iCP Centrifugal Pump with Xcoating™ 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 Terumo® Advanced Perfusion System 1/ Sarns™ Centrifugal Pump Systems or may be used with the Stockert / Sorin Centrifugal Pump Consoles.

Source page: https://510kreport.com/device/K200091
Methodology: https://510kreport.com/methodology