# K040210: Capiox RX25 Hollow Fiber Oxygenator W/WO Hardshell Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corp.
- Decided: Mar 3, 2004 after 33 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 K962667 (1996). 2 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962667: Capiox SX25 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir, Terumo Medical Corp. (1996) Summary page 2.
- K993772: X-Coated Capiox SX18 and SX25 Hollow Fiber Oxygenator with/ Without Detachable Hardshell Reservoir, Terumo Medical Corp. (2000) Summary page 4.

## Most influential descendants
- K062381: Capiox RX Oxygenator with or Without Reservoir (2006), 9 descendants of its own
- K130333: Capix RX Hollow Fiber Oxygenator with/Without Hardshell Reservoir (2013), 7 descendants of its own
- K071494: Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial Filter (2007), 7 descendants of its own
- K130520: Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir (2013), 6 descendants of its own
- K140774: Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir (2014), 5 descendants of its own

## Indications for use
The CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir is intended to be 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 blood and/or perfusion fluid as it flows through the device. The (detachable) hardshell reservoir is used to store blood during extra-corporeal circulation from both venous line and the cardiotomy line (via gravity or vacuum assisted venous drainage procedures). The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The Reservoir may also be used for Post-Operative Chest Drainage procedures. The CAPIOX® RX25 Oxygenator with/without Hardshell Reservoir can be used in procedures lasting up to 6 hours. The CAPIOX® RX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.

Source page: https://510kreport.com/device/K040210
Methodology: https://510kreport.com/methodology