# K070839: Modification to Capiox Flexible Venous Reservoir

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Apr 24, 2007 after 28 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- 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 K040023 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040023: Capiox Flexible Venous Reservoir, Terumo Cardiovascular Systems Corp. (2004) Summary page 1.

## Indications for use
The CAPIOX® Flexible Venous Reservoir is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit. The device may be used in procedures lasting up to 6 hours.

Source page: https://510kreport.com/device/K070839
Methodology: https://510kreport.com/methodology