# K970463: Capiox E Hollow Fiber Oxygenator with Integrated Heat Exchanger/Arterial Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: May 6, 1997 after 89 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
Longest line of descent: 1 generation back to K961000 (1996). 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)
- K961000: Capiox SX18 Hollow Fiber Oxygenator with and Without Detachable Hardshell Reservoir, Terumo Medical Corp. (1996) Summary page 2.

## Indications for use
The CAPIOX® E Hollow Fiber 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. The reservoir is used to store blood and the defoamer facilitates air removal. The device is intended for use during extracorporeal circulation for up to 6 hours.

Source page: https://510kreport.com/device/K970463
Methodology: https://510kreport.com/methodology