# K130493: Capiox RX05 Hollow Fiber Oxygenator/Reservoir

- Pathway: 510(k) (Special)
- Applicant: Terumo Corporation
- Decided: Mar 13, 2013 after 15 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: 2 generations back to K842908 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022115: Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell Reservoir, Terumo Corp. (2002) Summary page 2.

## Indications for use
The Capioxi RXO5 Hollow Fiber Oxygenator/Reservoiz device is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonaty bypass surgery. The integral heat exchanger is used to warmn or cool blood and/or perfusion fluid as it flows through the device. The (detachable) hardshiell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line (via gravity or vacuumi assisted venous drainage procedures). The reservoir contains a venous section that is comprised of a Filter and defoamner to faicilitate air bubble removal. The cardiotony section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The Capiox,& RXOS Oxygenator/Reservoir can be used( in procedures lasting uip to 6 hours. The Capiox RX05 is for use wvith neonatal and infantl patients when the required blood flowv rate will not exceed l.SL/Ain.

Source page: https://510kreport.com/device/K130493
Methodology: https://510kreport.com/methodology