510(k) · Cleared
Recalled · 2012Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Corp. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Jul 16, 2007 as substantially equivalent to K051997 (Terumo Cardiovascular Systems Corp., 2005) and 2 other predicates after a 47-day review. Its family tree reaches back 5 generations to 1992. 7 later devices descend from it. It has been recalled 12 times.
- Decided
- Jul 16, 2007
- Review
- 47 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 12
- Predicates
- 3
Its longest line of descent runs back 5 generations to K915573 (1992). 13 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK915573 Venous Reservoir W/Cardiotomy FilterBaxter Healthcare Corp · 1992
- 4 generations backK982223 Capiox SX Hardshell ResevoirTerumo Medical Corp. · 1998
- 3 generations backK991973 Capiox SX10 Hardshell ResevoirTerumo Medical Corp. · 1999
- 2 generations backK030449 Modification to Capiox SX10 Hardshell ReservoirTerumo Corp. · 2003
- 1 generation backK051997 Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2005 · Recalled
- This deviceK071494 Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial FilterTerumo Corp. · 2007
- Descendant · cites it directly · 6 of its ownK130520 Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirAshitaka Factory of Terumo Corp. · 2013
- Descendant · cites it directly · 5 of its ownK140774 Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirTerumo Cardiovascular Systems Corporation · 2014
- Descendant · 2 generations on · 2 of its ownK151791 Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial…Terumo Cardiovascular Systems Corporation · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK151389 Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial…Terumo Cardiovascular Systems Corporation · 2015
- Descendant · 3 generations on · 0 of its ownK242503 Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K130520Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirAshitaka Factory of Terumo Corp. · 2013 · cites it directly6descendants
- K140774Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirTerumo Cardiovascular Systems Corporation · 2014 · cites it directly5descendants
- K151791Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir…Terumo Cardiovascular Systems Corporation · 2015 · 2 generations on2descendants
- K151389Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell…Terumo Cardiovascular Systems Corporation · 2015 · 2 generations on1descendant
- K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915573 | Venous Reservoir W/Cardiotomy Filter | Baxter Healthcare Corp | 1992 | — |
| −4 | K982223 | Capiox SX Hardshell Resevoir | Terumo Medical Corp. | 1998 | — |
| −3 | K991973 | Capiox SX10 Hardshell Resevoir | Terumo Medical Corp. | 1999 | — |
| −2 | K030449 | Modification to Capiox SX10 Hardshell Reservoir | Terumo Corp. | 2003 | — |
| −1 | K051997 | Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir | Terumo Cardiovascular Systems Corp. | 2005 | 1 |
| 0 (this device) | K071494 | Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial Filter | Terumo Corp. | 2007 | — |
| +1 | 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 | — |
| +2 | K151791 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and… | Terumo Cardiovascular Systems Corporation | 2015 | 2 |
| +2 | K151389 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and… | Terumo Cardiovascular Systems Corporation | 2015 | — |
| +3 | K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | Eurosets S.R.L | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 2 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K051997 | Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirSummary page 4…voir that is used to collect and store blood during a cardiopulmonary bypass procedure. Note: The Hardshell Reservoirs have been previously cleared by FDA in K040210 and K051997. With respect to the design of the Arterial Filter, the filter contained within the oxygenator module is comprised of 32 micron… | 2005 |
| * | K040210 | Capiox RX25 Hollow Fiber Oxygenator W/WO Hardshell ReservoirSummary page 2…of operation, materials and specifications to the following devices: * Terumo's Capiox® RX15 Oxygenator/Reservoir- KO51997. * Terumo's Capiox® RX25 Oxygenator/Reservoir- K040210. * Terumo's Capiox® AF125X Arterial Filter- K052205 Intended Use: The Capiox FX Hollow Fiber Oxygenator and Arterial Filter is i… | 2004 |
| * | K052205 | Capiox AF125X Arterial FilterSummary page 2…llowing devices: * Terumo's Capiox® RX15 Oxygenator/Reservoir- KO51997. * Terumo's Capiox® RX25 Oxygenator/Reservoir- K040210. * Terumo's Capiox® AF125X Arterial Filter- K052205 Intended Use: The Capiox FX Hollow Fiber Oxygenator and Arterial Filter is intended to be used to exchange gases between blood a… | 2005 |
What descends from it? (7)
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 |
|---|---|---|---|---|
| Apr 12, 2012 | Not classified | Z-1526-2012 | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss |
| Apr 12, 2012 | Not classified | Z-1528-2012 | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss |
| Apr 12, 2012 | Not classified | Z-1530-2012 | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss |
| Apr 12, 2012 | Not classified | Z-1527-2012 | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss |
| Apr 12, 2012 | Not classified | Z-1533-2012 | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss |
| Apr 12, 2012 | Not classified | Z-1529-2012 | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss |
| Apr 12, 2012 | Not classified | Z-1532-2012 | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss |
| Apr 12, 2012 | Not classified | Z-1535-2012 | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss |
| Apr 12, 2012 | Not classified | Z-1531-2012 | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss |
| Apr 12, 2012 | Not classified | Z-1534-2012 | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss |
| Apr 12, 2012 | Not classified | Z-1524-2012 | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss |
| Apr 12, 2012 | Not classified | Z-1525-2012 | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K130520 (Ashitaka Factory of Terumo Corp., 2013) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K051997.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Hollow Fiber Oxygenator and Arterial Filter 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…
Read the full statement (241 words)
The Capiox FX Hollow Fiber Oxygenator and Arterial Filter 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 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min. when used with a 3 Liter Reservoir.
The Capiox FX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.
The Capiox FX Oxygenator/Reservoir/Arterial Filter assemblies can be used in procedures lasting up to 6 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071494: Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071494
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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