# K130280: Capiox FX Hollow Fiber Oxygenator W/ Reservoir

- Pathway: 510(k) (Special)
- Applicant: Terumo Corporation
- Decided: Mar 13, 2013 after 36 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: 3 generations back to K943917 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071572: Capiox FX05 Hollow Fiber Oxygenator with Integrated Arterial Filter, Terumo Corp. (2007) Summary page 2.

## Indications for use
The Capiox FX05 device is intended to be used during open heart surgical procedures to transfer oxygen and remove carbon dioxide from blood and to control the blood temperature during cardiopulmonary bypass for periods up to 6 hours. The Capiox FX05 is a Neonate/Infant oxygenator intended for use in procedures up to a maximum flow of 1.5 L/min. The patient weight and BSA should be considered upon use. The FX05 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures. The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit.

Source page: https://510kreport.com/device/K130280
Methodology: https://510kreport.com/methodology