# K012209: Capiox SP Pump with X-Coating Product Code: CXSP45X

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Aug 15, 2001 after 30 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 K962981 (1997). 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)
- K962981: Capiox SP Pump Head, Terumo Medical Corp. (1997) Summary page 1.

## Most influential descendants
- K080774: Capiox SP Pump (with or Without X-Coating) (2008), 0 descendants of its own

## Indications for use
The CAPIOX® SP Pump with X-Coating is used to facilitate blood flow in the extracorporeal circuit for circulatory support during extracorporeal circulation for up to 6 hours. The pump is a non-roller type pump and is a sterile device for single use only. The pump couples magnetically to, and is electrically driven by BioMedicus BioConsole Models 540 and 550 via the SP Pump Head adaptor. A biocompatible coating, polymethoxyethylacrylate (PMEA), is intended to reduce the adhesion of platelets to the blood-contacting surfaces of the device.

Source page: https://510kreport.com/device/K012209
Methodology: https://510kreport.com/methodology