# K180950: Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: Jun 22, 2018 after 72 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K915573 (1992). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151791: Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Cardiovascular Systems Corporation (2015) Summary page 4.

## Recalls of this device
- Mar 1, 2023 · Class II · Z-1346-2023: 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
- Jun 14, 2019 · Class II · Z-2101-2019: Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
- Jun 14, 2019 · Class II · Z-2103-2019: Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
- Jun 14, 2019 · Class II · Z-2102-2019: Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
- Jun 14, 2019 · Class II · Z-2104-2019: Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component

## Indications for use
The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of adult and small adult patients during cardiopulmonary bypass surgery. The integrated arterial filter is intended to filter non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit. The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device. The hardshell reservoir is used to store blood during extra-corporeal circulation from 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 4-liter reservoir may be used for Vacuum Assisted Drainage procedures and Post-Operative Chest Drainage Procedures. The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is for use with patients when the required blood flow rate will not exceed 8.0 L/min. The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology can be used in procedures lasting up to 6 hours.

Source page: https://510kreport.com/device/K180950
Methodology: https://510kreport.com/methodology