# K030505: Capiox Cardiotomy Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: May 14, 2003 after 84 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- 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 K002238 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013526: Capiox RX Hardshell Reservoir, Terumo Cardiovascular Systems Corp. (2001)

## Indications for use
The CAPIOX Cardiotomy Reservoir is designed to facilitate the removal of particulate matter and micro air bubbles from blood that is aspirated from the thoracic cavity and/or the left ventricle, and store it during extra corporeal circulation. The device may be used for procedures lasting up to 6 hours.

Source page: https://510kreport.com/device/K030505
Methodology: https://510kreport.com/methodology