# K993772: X-Coated Capiox SX18 and SX25 Hollow Fiber Oxygenator with/ Without Detachable Hardshell Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Jun 5, 2000 after 210 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
No predicates in its family tree.
16 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K040210: Capiox RX25 Hollow Fiber Oxygenator W/WO Hardshell Reservoir (2004), 12 descendants of its own
- 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
- K071494: Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial Filter (2007), 7 descendants of its own
- K130520: Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir (2013), 6 descendants of its own

## Recalls of this device
- Jun 28, 2010 · Not classified · Z-0842-2012: Complaints were received of expired X-coated Capiox SX18 Hollow Fiber oxygenators.

## Indications for use
The X-Coated CAPIOX® SX25 and SX18 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 X-Coat 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

Source page: https://510kreport.com/device/K993772
Methodology: https://510kreport.com/methodology