# K080774: Capiox SP Pump (with or Without X-Coating)

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Apr 17, 2008 after 29 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: 2 generations back to K852698 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012209: Capiox SP Pump with X-Coating Product Code: CXSP45X, Terumo Cardiovascular Systems Corp. (2001) Summary page 1.
- K962981: Capiox SP Pump Head, Terumo Medical Corp. (1997) Summary page 1.
- K973011: BPX80 Bio-Pump (BPX80), Medtronic Bio-Medicus, Inc. (1998) Summary page 1.

## Indications for use
The Capiox® SP Pump is used to facilitate blood flow in the extracorporeal circuit for circulatory support during extracorporeal circulation for up to 6 hours. Note: The Capiox® SP Pump is a sterile, single use device. The pump is a non-roller type pump that couples magnetically to, and is magnetically driven by the BioMedicus BioConsole Models 540, 550 and 560 via the pumphead adaptor.

Source page: https://510kreport.com/device/K080774
Methodology: https://510kreport.com/methodology