# K071494: Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial Filter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corp.
- Decided: Jul 16, 2007 after 47 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K915573 (1992). 13 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051997: Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir, Terumo Cardiovascular Systems Corp. (2005) Summary page 4.
- K040210: Capiox RX25 Hollow Fiber Oxygenator W/WO Hardshell Reservoir, Terumo Corp. (2004) Summary page 2.
- K052205: Capiox AF125X Arterial Filter, Terumo Cardiovascular Systems Corp. (2005) Summary page 2.

## Most influential descendants
- 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
- K151791: Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir (2015), 2 descendants of its own
- K151389: Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir (2015), 1 descendant of its own
- K242503: Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) (2025), 0 descendants of its own

## Recalls of this device
- Apr 12, 2012 · Not classified · Z-1526-2012: Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
- Apr 12, 2012 · Not classified · Z-1528-2012: Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
- Apr 12, 2012 · Not classified · Z-1530-2012: Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
- Apr 12, 2012 · Not classified · Z-1527-2012: Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
- Apr 12, 2012 · Not classified · Z-1533-2012: Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
- Apr 12, 2012 · Not classified · Z-1529-2012: Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
- Apr 12, 2012 · Not classified · Z-1532-2012: Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
- Apr 12, 2012 · Not classified · Z-1535-2012: Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
- Apr 12, 2012 · Not classified · Z-1531-2012: Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
- Apr 12, 2012 · Not classified · Z-1534-2012: Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
- Apr 12, 2012 · Not classified · Z-1524-2012: Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
- Apr 12, 2012 · Not classified · Z-1525-2012: Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss

## Indications for use
The Capiox FX Hollow Fiber Oxygenator and Arterial Filter 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 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. The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device. The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. 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 3-liter and 4-liter reservoirs may be used for Vacuum Assisted Drainage procedures and Post Operative Chest Drainage Procedures. The Capiox FX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min. when used with a 3 Liter Reservoir. The Capiox FX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min. The Capiox FX Oxygenator/Reservoir/Arterial Filter assemblies can be used in procedures lasting up to 6 hours.

Source page: https://510kreport.com/device/K071494
Methodology: https://510kreport.com/methodology