510(k) · Cleared
Recalled · Class II · 2023Terumo 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)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corporation · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Jun 22, 2018 as substantially equivalent to K151791 (Terumo Cardiovascular Systems Corporation, 2015) after a 72-day review. Its family tree reaches back 9 generations to 1992. It has been recalled 5 times.
- Decided
- Jun 22, 2018
- Review
- 72 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 9 generations to K915573 (1992). 21 ancestors in all, the oldest K842908 (1985). No later device cites it as a predicate yet.
- Root · 9 generations backK915573 Venous Reservoir W/Cardiotomy FilterBaxter Healthcare Corp · 1992
- 5 generations between
- 3 generations backK130520 Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirAshitaka Factory of Terumo Corp. · 2013
- 2 generations backK140774 Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirTerumo Cardiovascular Systems Corporation · 2014
- 1 generation backK151791 Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial…Terumo Cardiovascular Systems Corporation · 2015 · Recalled
- This deviceK180950 Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation)…Terumo Cardiovascular Systems Corporation · 2018
Show all 9 generations
- Root · 9 generations backK915573 Venous Reservoir W/Cardiotomy FilterBaxter Healthcare Corp · 1992
- 8 generations backK982223 Capiox SX Hardshell ResevoirTerumo Medical Corp. · 1998
- 7 generations backK991973 Capiox SX10 Hardshell ResevoirTerumo Medical Corp. · 1999
- 6 generations backK030449 Modification to Capiox SX10 Hardshell ReservoirTerumo Corp. · 2003
- 5 generations backK051997 Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2005 · Recalled
- 4 generations backK071494 Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial FilterTerumo Corp. · 2007 · Recalled
- 3 generations backK130520 Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirAshitaka Factory of Terumo Corp. · 2013
- 2 generations backK140774 Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirTerumo Cardiovascular Systems Corporation · 2014
- 1 generation backK151791 Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial…Terumo Cardiovascular Systems Corporation · 2015 · Recalled
- This deviceK180950 Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation)…Terumo Cardiovascular Systems Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K915573 | Venous Reservoir W/Cardiotomy Filter | Baxter Healthcare Corp | 1992 | — |
| −8 | K982223 | Capiox SX Hardshell Resevoir | Terumo Medical Corp. | 1998 | — |
| −7 | K991973 | Capiox SX10 Hardshell Resevoir | Terumo Medical Corp. | 1999 | — |
| −6 | K030449 | Modification to Capiox SX10 Hardshell Reservoir | Terumo Corp. | 2003 | — |
| −5 | K051997 | Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir | Terumo Cardiovascular Systems Corp. | 2005 | 1 |
| −4 | K071494 | Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial Filter | Terumo Corp. | 2007 | 12 |
| −3 | K130520 | Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir | Ashitaka Factory of Terumo Corp. | 2013 | — |
| −2 | K140774 | Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir | Terumo Cardiovascular Systems Corporation | 2014 | — |
| −1 | K151791 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and… | Terumo Cardiovascular Systems Corporation | 2015 | 2 |
| 0 (this device) | K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox… | Terumo Cardiovascular Systems Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DTZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DTZ device
- #1 K240934 Quantum Perfusion Blood Oxygenator ECC…score 14.3 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151791 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir…Summary page 4…s and specifications to the following devices: x Terumo® Capiox“ FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir – K151791 Reference Devices: x Sorin Inspire 8F Oxygenator with Integrated Arterial Filter and Hardshell Reservoir- K121… | 2015 |
| † | K121536 | Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell Reservoir | 2012 |
| † | K172071 | Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2023 | Class II | Z-1346-2023 | Process control | 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 thermistor is improperly bonded to the… |
| Jun 14, 2019 | Class II | Z-2101-2019 | Process control | Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component |
| Jun 14, 2019 | Class II | Z-2103-2019 | Process control | Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component |
| Jun 14, 2019 | Class II | Z-2102-2019 | Process control | Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component |
| Jun 14, 2019 | Class II | Z-2104-2019 | Process control | Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 21 ancestors have a recall of any class.
- 1 other device also cites its predicate K151791.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DTZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTZ
124in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTZ
1in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DTZ
976in 2025
MAUDE reports naming product code DTZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 55 | 7 | 134 |
| 2008 | 3 | 88 | 5 | 105 |
| 2009 | 9 | 210 | 0 | 52 |
| 2010 | 2 | — | 1 | 119 |
| 2011 | 4 | 160 | 13 | 190 |
| 2012 | 9 | 90 | 14 | 215 |
| 2013 | 9 | 28 | 0 | 346 |
| 2014 | 5 | 28 | 2 | 764 |
| 2015 | 9 | 134 | 0 | 658 |
| 2016 | 3 | 62 | 1 | 443 |
| 2017 | 2 | — | 0 | 388 |
| 2018 | 3 | 72 | 2 (2) | 320 |
| 2019 | 5 | 90 | 1 | 489 |
| 2020 | 5 | 93 | 3 | 442 |
| 2021 | 5 | 336 | 1 (1) | 595 |
| 2022 | 2 | — | 6 | 559 |
| 2023 | 5 | 145 | 0 | 738 |
| 2024 | 3 | 124 | 0 | 535 |
| 2025 | 2 | — | 1 | 976 |
| 2026 | 3 | 137 | 0 | — |
What is it indicated for?
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…
Read the full statement (211 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180950 · printed Nov 4, 2026
Cite this page
510(k) Report. “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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180950
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026