510(k) · Cleared
ClearedCapiox RX25 Hollow Fiber Oxygenator W/WO Hardshell Reservoir
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 Mar 3, 2004 as substantially equivalent to K962667 (Terumo Medical Corp., 1996) and 1 other predicate after a 33-day review. Its family tree reaches back 1 generation to 1996. 12 later devices descend from it.
- Decided
- Mar 3, 2004
- Review
- 33 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K962667 (1996). 2 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK962667 Capiox SX25 Hollow Fiber Oxygenator with Detachable Hardshell…Terumo Medical Corp. · 1996
- This deviceK040210 Capiox RX25 Hollow Fiber Oxygenator W/WO Hardshell ReservoirTerumo Corp. · 2004
- Descendant · cites it directly · 9 of its ownK062381 Capiox RX Oxygenator with or Without ReservoirTerumo Cardiovascular Systems Corp. · 2006 · 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
- Descendant · 2 generations on · 6 of its ownK130520 Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirAshitaka Factory of Terumo Corp. · 2013
- Descendant · 2 generations on · 5 of its ownK140774 Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirTerumo Cardiovascular Systems Corporation · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K062381Capiox RX Oxygenator with or Without ReservoirTerumo Cardiovascular Systems Corp. · 2006 · cites it directly9descendants
- 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
- K130520Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirAshitaka Factory of Terumo Corp. · 2013 · 2 generations on6descendants
- K140774Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirTerumo Cardiovascular Systems Corporation · 2014 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962667 | Capiox SX25 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir | Terumo Medical Corp. | 1996 | — |
| 0 (this device) | K040210 | Capiox RX25 Hollow Fiber Oxygenator W/WO Hardshell Reservoir | Terumo Corp. | 2004 | — |
| +1 | K062381 | Capiox RX Oxygenator with or Without Reservoir | Terumo Cardiovascular Systems Corp. | 2006 | 2 |
| +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 |
| +2 | K130520 | Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir | Ashitaka Factory of Terumo Corp. | 2013 | — |
| +2 | K140774 | Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir | Terumo Cardiovascular Systems Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K962667 | Capiox SX25 Hollow Fiber Oxygenator with Detachable Hardshell ReservoirSummary page 2…nded use, design, technology/principles of operation, materials and specifications following devices: · Terumo's CAPIOX® SX25 Oxygenator w/wo Hardshell Reservoir - K962667. Intended Use: is intended to The CAPIOX® RX25… | 1996 |
| * | K993772 | X-Coated Capiox SX18 and SX25 Hollow Fiber Oxygenator with/ Without Detachable Hardshell…Summary page 4…the predicate SX25 Oxygenators effectiveness. The X-Coating polymer is also present on and Reservoirs cleared by FDA in K993772. and the predicate is the The most nota… | 2000 |
What descends from it? (12)
See all 123 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?
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® RX25 Hollow Fiber Oxygenator with/without 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 integral heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device. The (detachable) hardshell reservoir is used to store blood during extra-corporeal circulation from both…
Read the full statement (171 words)
The CAPIOX® RX25 Hollow Fiber Oxygenator with/without 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 integral heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.
The (detachable) hardshell reservoir is used to store blood during extra-corporeal circulation from both venous line and the cardiotomy line (via gravity or vacuum assisted venous drainage procedures). 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 Reservoir may also be used for Post-Operative Chest Drainage procedures.
The CAPIOX® RX25 Oxygenator with/without Hardshell Reservoir can be used in procedures lasting up to 6 hours.
The CAPIOX® RX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040210: Capiox RX25 Hollow Fiber Oxygenator W/WO 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/K040210
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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