510(k) · Cleared
ClearedCapiox SX18 Hollow Fiber Oxygenator with and Without Detachable Hardshell 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 2, 1996 after a 204-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Oct 2, 1996
- Review
- 204 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK961000 Capiox SX18 Hollow Fiber Oxygenator with and Without Detachable…Terumo Medical Corp. · 1996
- Descendant · cites it directly · 2 of its ownK130359 Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell…Terumo Cardiovascular Systems Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK153143 Capiox Advance Hardshell ReservoirTerumo Cardiovascular Systems Corporation · 2015
- Descendant · 2 generations on · 0 of its ownK153140 Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox…Terumo Cardiovascular Systems Corp. · 2015
- Descendant · cites it directly · 0 of its ownK970463 Capiox E Hollow Fiber Oxygenator with Integrated Heat…Terumo Medical Corp. · 1997
Most influential descendants
Showing 4 of 4 · See all- K130359Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir, Capiox SX25…Terumo Cardiovascular Systems Corp. · 2013 · cites it directly2descendants
- K153143Capiox Advance Hardshell ReservoirTerumo Cardiovascular Systems Corporation · 2015 · 2 generations on0descendants
- K153140Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/…Terumo Cardiovascular Systems Corp. · 2015 · 2 generations on0descendants
- K970463Capiox E Hollow Fiber Oxygenator with Integrated Heat Exchanger/Arterial ReservoirTerumo Medical Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961000 | Capiox SX18 Hollow Fiber Oxygenator with and Without Detachable Hardshell… | Terumo Medical Corp. | 1996 | — |
| +1 | K130359 | Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir… | Terumo Cardiovascular Systems Corp. | 2013 | — |
| +2 | K153143 | Capiox Advance Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015 | — |
| +2 | K153140 | Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18… | Terumo Cardiovascular Systems Corp. | 2015 | — |
| +1 | K970463 | Capiox E Hollow Fiber Oxygenator with Integrated Heat Exchanger/Arterial… | Terumo Medical Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | — | Cobe CML Excel Named without a submission number |
What descends from it? (4)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K130359 (Terumo Cardiovascular Systems Corp., 2013) has gone furthest, with 2 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 | — |
What is it indicated for?
The CAPIOX® SX18 Hollow Fiber Oxygenator is used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery. The integral heat exchanger is used to warm or cool the blood or perfusion fluid flowing through the device.
The CAPIOX SX18 Hardshell Reservoir (detachable) is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.
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/K961000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961000: Capiox SX18 Hollow Fiber Oxygenator with and Without Detachable Hardshell Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961000
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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