# K022115: Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corp.
- Decided: Sep 27, 2002 after 88 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 K842908 (1985). 2 ancestors in all.
26 later devices descend from it; 8 cite it directly.
2 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933586: Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive Surface, Medtronic Vascular (1994) Summary page 3.
- K842908: Variable Prime Cobe Membrane Lung, Cobe Laboratories, Inc. (1985) Summary page 3.

## 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
- K102464: Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline/Bioline Coating (2011), 6 descendants of its own
- K140774: Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir (2014), 5 descendants of its own
- K132829: Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators (2013), 4 descendants of its own

## Indications for use
The CAPIOXO RX05 Hollow Fiber Oxygenator witWwithout 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 cardiopulnioiiary bypass surgery. 'The integral heat exchanger is used to ivarrn or cool blood and/or perfusion fluid as it flows through the device. The (detachable) hardshell reservoir is used to store blood during extracorporeal circulation from both venous line and the cardiotomy line (via gravity or vacuum assisted venous drainage procedurcs). 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 CAPIOXO RX05 Oxygenator witWwithout hardshell reservoir can be used in procedures lasting up to 6 hours. The CAPIOXO RX05 is for use with neonatal and infant patients when the required blood flow rate will not exceed 1.5 L/min.

Source page: https://510kreport.com/device/K022115
Methodology: https://510kreport.com/methodology