# K040023: Capiox Flexible Venous Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Mar 1, 2004 after 54 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Baxter/Bentley BMR1900G Venous Reservoir (w/ Duraflo Treatment): named in the summary without a submission number

## Most influential descendants
- K070839: Modification to Capiox Flexible Venous Reservoir (2007), 0 descendants of its own

## Indications for use
The CAPIOX® Flexible Venous 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 in duration.

Source page: https://510kreport.com/device/K040023
Methodology: https://510kreport.com/methodology