# K051997: Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Sep 15, 2005 after 52 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K915573 (1992). 7 ancestors in all.
25 later devices descend from it; 5 cite it directly.
2 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960074: Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous Reservoir, Terumo Medical Corp. (1996) Summary page 2.
- K030449: Modification to Capiox SX10 Hardshell Reservoir, Terumo Corp. (2003) Summary page 2.
- K933586: Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive Surface, Medtronic Vascular (1994) Summary page 2.

## Most influential descendants
- K090689: Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline Coating, Models Hmo 50000, Hmo 51000 (2009), 9 descendants of its own
- K062381: Capiox RX Oxygenator with or Without Reservoir (2006), 9 descendants of its own
- K093522: Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/ Integrated Arterial Filter W/ Bioline C (2009), 8 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

## Recalls of this device
- Apr 12, 2012 · Not classified · Z-1523-2012: 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 RXI5 is intended to be used during open-heart surgical procedures requiring cardiopulmonary bypass for period up to 6 hours. The Capiox RX15 is for use with patients when required blood flow rate will not exceed 5 L/min (4 Llmin if using the CX*RX15RW30 product code or CX*RXI5RE30 Product code). The Capiox RX15 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures, in post-operative chest drainage, and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement.

Source page: https://510kreport.com/device/K051997
Methodology: https://510kreport.com/methodology