510(k) · Cleared
Recalled · 2012Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Sep 15, 2005 as substantially equivalent to K960074 (Terumo Medical Corp., 1996) and 2 other predicates after a 52-day review. Its family tree reaches back 4 generations to 1992. 2 of the 33 devices in its family, counting itself, have a Class I recall. 25 later devices descend from it. It has been recalled once.
- Decided
- Sep 15, 2005
- Review
- 52 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K915573 (1992). 7 ancestors in all. 25 later devices descend from it, 5 citing it directly. 2 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK915573 Venous Reservoir W/Cardiotomy FilterBaxter Healthcare Corp · 1992
- 3 generations backK982223 Capiox SX Hardshell ResevoirTerumo Medical Corp. · 1998
- 2 generations backK991973 Capiox SX10 Hardshell ResevoirTerumo Medical Corp. · 1999
- 1 generation backK030449 Modification to Capiox SX10 Hardshell ReservoirTerumo Corp. · 2003
- This deviceK051997 Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2005
- Descendant · cites it directly · 9 of its ownK090689 Quadrox-I Small Adult with and Without Intergrated Arterial Filter…Maquet Cardiopulmonary, AG · 2009 · Recalled
- Descendant · cites it directly · 9 of its ownK062381 Capiox RX Oxygenator with or Without ReservoirTerumo Cardiovascular Systems Corp. · 2006 · Recalled
- Descendant · 2 generations on · 8 of its ownK093522 Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- Descendant · 2 generations on · 7 of its ownK130333 Capix RX Hollow Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2013
- Descendant · cites it directly · 7 of its ownK071494 Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial FilterTerumo Corp. · 2007 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 25 · See all- K090689Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline…Maquet Cardiopulmonary, AG · 2009 · cites it directly9descendants
- K062381Capiox RX Oxygenator with or Without ReservoirTerumo Cardiovascular Systems Corp. · 2006 · cites it directly9descendants
- K093522Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Maquet Cardiopulmonary, AG · 2009 · 2 generations on8descendants
- K130333Capix RX Hollow Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2013 · 2 generations on7descendants
- K071494Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial FilterTerumo Corp. · 2007 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915573 | Venous Reservoir W/Cardiotomy Filter | Baxter Healthcare Corp | 1992 | — |
| −3 | K982223 | Capiox SX Hardshell Resevoir | Terumo Medical Corp. | 1998 | — |
| −2 | K991973 | Capiox SX10 Hardshell Resevoir | Terumo Medical Corp. | 1999 | — |
| −1 | K030449 | Modification to Capiox SX10 Hardshell Reservoir | Terumo Corp. | 2003 | — |
| 0 (this device) | K051997 | Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir | Terumo Cardiovascular Systems Corp. | 2005 | — |
| +1 | K090689 | Quadrox-I Small Adult with and Without Intergrated Arterial Filter with… | Maquet Cardiopulmonary, AG | 2009 | 5 |
| +1 | K062381 | Capiox RX Oxygenator with or Without Reservoir | Terumo Cardiovascular Systems Corp. | 2006 | 2 |
| +2 | K093522 | Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and… | Maquet Cardiopulmonary, AG | 2009 | 3 |
| +2 | K130333 | Capix RX Hollow Fiber Oxygenator with/Without Hardshell Reservoir | Terumo Cardiovascular Systems Corp. | 2013 | — |
| +1 | K071494 | Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial Filter | Terumo Corp. | 2007 | 12 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 4 | 0 |
| 2011 | 2 | 1 |
| 2013 | 4 | 0 |
| 2014 | 3 | 1 |
| 2015 | 4 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K960074 | Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous ReservoirSummary page 2…y equivalent in intended use, design, technology/principles of operation, materials and specifications to the following devices: Terumo's CAPIOX® SXl 1Oxygenator - K960074. Terumo's CAPIOX® SXIO Hardshell Reservoir - K030449. Medtronic Minimax Plus Oxygenator - K933586. Intended Use: The C… | 1996 |
| * | K030449 | Modification to Capiox SX10 Hardshell ReservoirSummary page 2…s of operation, materials and specifications to the following devices: Terumo's CAPIOX® SXl 1Oxygenator - K960074. Terumo's CAPIOX® SXIO Hardshell Reservoir - K030449. Medtronic Minimax Plus Oxygenator - K933586. Intended Use: The CAPIOX® RXI5 Hollow Fiber Oxygenator with/without Hardshell… | 2003 |
| * | K933586 | Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive SurfaceSummary page 2…e following devices: Terumo's CAPIOX® SXl 1Oxygenator - K960074. Terumo's CAPIOX® SXIO Hardshell Reservoir - K030449. Medtronic Minimax Plus Oxygenator - K933586. Intended Use: The CAPIOX® RXI5 Hollow Fiber Oxygenator with/without Hardshell Reservoir is intended to be used to exchange gase… | 1994 |
What descends from it? (25)
See all 255 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090689 | Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline… | 2009 | 9 |
| K062381 | Capiox RX Oxygenator with or Without Reservoir | 2006 | 9 |
| K071494 | Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial Filter | 2007 | 7 |
| K090450 | Medos Hilite Pediatric Oxygenator, Models 2800, 2400 LT | 2009 | 2 |
| K082321 | Terumo Rocsafe Hybrid Perfusion System | 2009 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 12, 2012 | Not classified | Z-1523-2012 | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K090689 (Maquet Cardiopulmonary, AG, 2009) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K960074.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 RXI5 is intended to be used during open-heart surgical procedures requiring cardiopulmonary bypass for period up to 6 hours. The Capiox RX15 is for use with patients when required blood flow rate will not exceed 5 L/min (4 Llmin if using the CX*RX15RW30 product code or CX*RXI5RE30 Product code).
The Capiox RX15 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures, in post-operative chest drainage, and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051997 · printed Nov 3, 2026
Cite this page
510(k) Report. “K051997: Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K051997
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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