510(k) · Cleared
ClearedCapiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous Reservoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Oct 16, 1996 after a 279-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 45 devices in its family, counting itself, have a Class I recall. 44 later devices descend from it.
- Decided
- Oct 16, 1996
- Review
- 279 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 0
44 later devices descend from it, 3 citing it directly. 2 of the 45 devices in this family, counting this one, have a Class I recall.
- This deviceK960074 Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous…Terumo Medical Corp. · 1996
- Descendant · cites it directly · 25 of its ownK051997 Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2005 · Recalled
- Descendant · cites it directly · 19 of its ownK991452 Cobe Optimin Hollow Fiber Membrane OxygenatorCobe Cardiovascular, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 17 of its ownK043323 D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell…Dideco S.R.L. · 2005 · Recalled
- Descendant · 2 generations on · 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
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 44 · See all- K051997Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2005 · cites it directly25descendants
- K991452Cobe Optimin Hollow Fiber Membrane OxygenatorCobe Cardiovascular, Inc. · 1999 · cites it directly19descendants
- K043323D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirDideco S.R.L. · 2005 · 2 generations on17descendants
- K090689Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline…Maquet Cardiopulmonary, AG · 2009 · 2 generations on9descendants
- K062381Capiox RX Oxygenator with or Without ReservoirTerumo Cardiovascular Systems Corp. · 2006 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960074 | Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous Reservoir | Terumo Medical Corp. | 1996 | — |
| +1 | K051997 | Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir | Terumo Cardiovascular Systems Corp. | 2005 | 1 |
| +1 | K991452 | Cobe Optimin Hollow Fiber Membrane Oxygenator | Cobe Cardiovascular, Inc. | 1999 | 2 |
| +2 | K043323 | D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy… | Dideco S.R.L. | 2005 | 1 |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2011 | 2 | 1 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 1 |
| 2015 | 5 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (44)
See all 443 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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?
- Of its descendants, K051997 (Terumo Cardiovascular Systems Corp., 2005) has gone furthest, with 25 descendants of its own.
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 | — |
https://510kreport.com/device/K960074 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960074: Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960074
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026