# K130333: Capix RX Hollow Fiber Oxygenator with/Without Hardshell Reservoir

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Mar 13, 2013 after 30 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: 6 generations back to K915573 (1992). 14 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062381: Capiox RX Oxygenator with or Without Reservoir, Terumo Cardiovascular Systems Corp. (2006) Summary page 4.

## Most influential descendants
- 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
- 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

## Indications for use
The CAPIOX RX is intended to be used during open heart surgical procedures requiring cardiopulmonary bypass for periods up to 6 hours. The CAPIOX RX25 is used with patients when required blood flow rate will not exceed 7 L/min. The CAPIOX 10(15 is for use with patients when required blood flow rate will not exceedS5 L/min (4L/min if using product codes CX*RXI5RW3O or CX*RX15RE3O). The CAPIOX RX l-ardshell Reservoir is also intended for use in vacuum assisted venous drainage procedure, in post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement. The CAPIOXo RN Hollow Fiber Oxygenators with/without Hardshell Reservoir are 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 perfujsion fluid as it flows through the device. The (detachable) hardshell reservoir(s) is (are) 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 mailer and a defoamer to facilitate air bubble removal. The reservoir may also be used for Post Operative Chest Drainage Procedures. The CAPIOXO RX Oxygenators with/without Hardshell Reservoirs can be used in procedures lasting up to 6 hours. The CAPION' R.X15 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 CAPIOXD 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/K130333
Methodology: https://510kreport.com/methodology