# K140774: Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: Jun 2, 2014 after 66 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: 7 generations back to K915573 (1992). 19 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071494: Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial Filter, Terumo Corp. (2007) Summary page 2.
- K130520: Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir, Ashitaka Factory of Terumo Corp. (2013) Summary page 2.
- K130333: Capix RX Hollow Fiber Oxygenator with/Without Hardshell Reservoir, Terumo Cardiovascular Systems Corp. (2013) Summary page 2.

## Most influential descendants
- 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
- K180950: Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) (2018), 0 descendants of its own
- K172071: Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo  Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo  Capiox  NX19 Oxygenator (west orientation) (2018), 0 descendants of its own

## 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 entoll and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit. The integrated heat exchanger is wsed 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 deframer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a det'oamer to facilitate air bubble removal. The 3-iter and 4-liter reservoirs may be used fur Vacuum Assisted Drainage procedures and Post Operative Chest Drainage Procedures. The Cap lox P1X15 is fbr 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/nin. when used with a 3 Liter Reservoir. The Capiox PX2S is for use with patients when the required blood flow rate will not exceed 7.0 L/min. Theo Capiox FX Oxygenator/Reservoir/Arterial Filter assemblies can be used in procedures lasting up to 6 hours.

Source page: https://510kreport.com/device/K140774
Methodology: https://510kreport.com/methodology