# K962981: Capiox SP Pump Head

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Feb 25, 1997 after 208 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.
2 later devices descend from it; 2 cite 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K012209: Capiox SP Pump with X-Coating Product Code: CXSP45X (2001), 1 descendant of its own
- K080774: Capiox SP Pump (with or Without X-Coating) (2008), 0 descendants of its own

## Recalls of this device
- Jul 26, 2005 · Not classified · Z-0140-06: Small cracks in the blood chamber may allow air to enter the rotor of the device

Source page: https://510kreport.com/device/K962981
Methodology: https://510kreport.com/methodology