# K130359: Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir, Capiox SX25 Hollow Fiber Oxgenator with Detacha

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Mar 13, 2013 after 28 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: 2 generations back to K002238 (2000). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961000: Capiox SX18 Hollow Fiber Oxygenator with and Without Detachable Hardshell Reservoir, Terumo Medical Corp. (1996) Summary page 5.
- K962667: Capiox SX25 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir, Terumo Medical Corp. (1996) Summary page 3.
- K993772: X-Coated Capiox SX18 and SX25 Hollow Fiber Oxygenator with/ Without Detachable Hardshell Reservoir, Terumo Medical Corp. (2000) Summary page 3.
- K013526: Capiox RX Hardshell Reservoir, Terumo Cardiovascular Systems Corp. (2001) Summary page 5.

## Most influential descendants
- K153143: Capiox Advance Hardshell Reservoir (2015), 0 descendants of its own
- K153140: Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating (2015), 0 descendants of its own

## Indications for use
The (X-Coated) Capiox® SX25 and SX 18 Hollow Fiber Oxygenators with/without Detachable Hardshell Reservoirs are used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery for periods up to 6 hours. The integral heat exchanger is used to warm or cool blood or perfusion fluid as it flows through the device. The (detachable) hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. 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 Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement. The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass. (The X-CoatingTM is a polymer coating that is applied to blood contacting surfaces of the oxygenator to reduce the adhesion of platelets to the surfaces of the device.) The Capiox® Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal. The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return blood to the patient for blood volume replacement. The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass. The Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device. The device may be used for procedures lasting up to 6 hours.

Source page: https://510kreport.com/device/K130359
Methodology: https://510kreport.com/methodology