510(k) · Cleared
Recalled · Class II · 2023Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir
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 Nov 19, 2015 as substantially equivalent to K140774 (Terumo Cardiovascular Systems Corporation, 2014) after a 141-day review. Its family tree reaches back 8 generations to 1992. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 19, 2015
- Review
- 141 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 8 generations to K915573 (1992). 20 ancestors in all, the oldest K842908 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK915573 Venous Reservoir W/Cardiotomy FilterBaxter Healthcare Corp · 1992
- 7 generations backK982223 Capiox SX Hardshell ResevoirTerumo Medical Corp. · 1998
- 6 generations backK991973 Capiox SX10 Hardshell ResevoirTerumo Medical Corp. · 1999
- 5 generations backK030449 Modification to Capiox SX10 Hardshell ReservoirTerumo Corp. · 2003
- 4 generations backK051997 Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2005 · Recalled
- 3 generations backK071494 Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial FilterTerumo Corp. · 2007 · Recalled
- 2 generations backK130520 Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirAshitaka Factory of Terumo Corp. · 2013
- 1 generation backK140774 Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirTerumo Cardiovascular Systems Corporation · 2014
- This deviceK151791 Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial…Terumo Cardiovascular Systems Corporation · 2015
- Descendant · cites it directly · 0 of its ownK180950 Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation)…Terumo Cardiovascular Systems Corporation · 2018 · Recalled
- Descendant · cites it directly · 0 of its ownK172071 Terumo Capiox NX19 Oxygenator with Reservoir (east orientation )…Terumo Cardiovascular Systems Corporation · 2018
Most influential descendants
Showing 2 of 2 · See all- K180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19…Terumo Cardiovascular Systems Corporation · 2018 · cites it directly0descendants
- K172071Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19…Terumo Cardiovascular Systems Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K915573 | Venous Reservoir W/Cardiotomy Filter | Baxter Healthcare Corp | 1992 | — |
| −7 | K982223 | Capiox SX Hardshell Resevoir | Terumo Medical Corp. | 1998 | — |
| −6 | K991973 | Capiox SX10 Hardshell Resevoir | Terumo Medical Corp. | 1999 | — |
| −5 | K030449 | Modification to Capiox SX10 Hardshell Reservoir | Terumo Corp. | 2003 | — |
| −4 | K051997 | Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir | Terumo Cardiovascular Systems Corp. | 2005 | 1 |
| −3 | K071494 | Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial Filter | Terumo Corp. | 2007 | 12 |
| −2 | K130520 | Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir | Ashitaka Factory of Terumo Corp. | 2013 | — |
| −1 | K140774 | Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir | Terumo Cardiovascular Systems Corporation | 2014 | — |
| 0 (this device) | K151791 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and… | Terumo Cardiovascular Systems Corporation | 2015 | — |
| +1 | K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox… | Terumo Cardiovascular Systems Corporation | 2018 | 5 |
| +1 | K172071 | Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo… | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K140774 | Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirSummary page 4…tion, materials and specifications to the following devices: Terumo® Capiox“ FX Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Reservoir – K140774. Intended Use The Capiox“ FX Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir is intended to be used t… | 2014 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-1347-2023 | 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… |
| Nov 11, 2020 | Class II | Z-0565-2021 | Labeling mix-ups | Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K180950 (Terumo Cardiovascular Systems Corporation, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K140774.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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® FX Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir is 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 integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit. The…
Read the full statement (232 words)
The Capiox® FX Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir is 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 integrated arterial filter is intended to filtrate 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 3-liter and 4-liter reservoirs may be used for Vacuum Assisted Drainage procedures and Post Operative Chest Drainage Procedures.
The Capiox® FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir (both 3-liter and 4-liter) is for use with patients when the required blood flow rate will not exceed 5.0 L/min. The Capiox® FX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.
The Capiox® FX Advance Oxygenator/Reservoir/Arterial Filter assemblies can be used in procedures lasting up to 6 hours.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151791: Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151791
Report an extraction error
Are you the manufacturer?
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