# K961734: Capiox 308 Hollow Fiber Oxygenator W/Integrated Heat Exchange

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Jul 7, 1997 after 430 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Avecor 0800 2A Oxygenator: named in the summary without a submission number
- (no number) Omnitherm Heat Exchanger: named in the summary without a submission number

## Indications for use
The CAPIOX 308 Oxygenator is used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery. The integral heat exchanger is used to warm or cool the blood or perfusion fluid flowing through the device. This device is for use during extracorporeal circulation for up to 6 hours. This device is for use with neonatal and pediatric patients.

Source page: https://510kreport.com/device/K961734
Methodology: https://510kreport.com/methodology