# K062381: Capiox RX Oxygenator with or Without Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Aug 24, 2006 after 9 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 2 (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.
9 later devices descend from it; 2 cite it directly.
0 of 23 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.
- K993772: X-Coated Capiox SX18 and SX25 Hollow Fiber Oxygenator with/ Without Detachable Hardshell Reservoir, Terumo Medical Corp. (2000) Summary page 2.
- K051997: Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir, Terumo Cardiovascular Systems Corp. (2005) Summary page 2.
- K040210: Capiox RX25 Hollow Fiber Oxygenator W/WO Hardshell Reservoir, Terumo Corp. (2004) Summary page 2.
- K022115: Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell Reservoir, Terumo Corp. (2002) Summary page 2.

## Most influential descendants
- K130333: Capix RX Hollow Fiber Oxygenator with/Without Hardshell Reservoir (2013), 7 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
- Mar 1, 2023 · Class II · Z-1345-2023: Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermisto
- 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® RX 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 perfusion 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 matter and a defoamer to facilitate air bubble removal. The reservoir may also be used for Post Operative Chest Drainage Procedures. The CAPIOX® RX Oxygenators with/without Hardshell Reservoirs can be used in procedures lasting up to 6 hours. The CAPIOX® RX15 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® RX25 is for use with patients when the required blood flow rate will not exceed 70 L/min.

Source page: https://510kreport.com/device/K062381
Methodology: https://510kreport.com/methodology