510(k) · Cleared
ClearedCapiox RX05 Hollow Fiber Oxygenator W/Without 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 Sep 27, 2002 as substantially equivalent to K933586 (Medtronic Vascular, 1994) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1985. 2 of the 29 devices in its family, counting itself, have a Class I recall. 26 later devices descend from it.
- Decided
- Sep 27, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K842908 (1985). 2 ancestors in all. 26 later devices descend from it, 8 citing it directly. 2 of the 29 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK842908 Variable Prime Cobe Membrane LungCobe Laboratories, Inc. · 1985
- This deviceK022115 Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell ReservoirTerumo Corp. · 2002
- 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 · 6 of its ownK102464 Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated…Maquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 5 of its ownK140774 Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirTerumo Cardiovascular Systems Corporation · 2014
- Descendant · 2 generations on · 4 of its ownK132829 Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG · 2013 · Recalled
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 26 · 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
- K102464Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2011 · cites it directly6descendants
- K140774Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirTerumo Cardiovascular Systems Corporation · 2014 · 3 generations on5descendants
- K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG · 2013 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842908 | Variable Prime Cobe Membrane Lung | Cobe Laboratories, Inc. | 1985 | — |
| 0 (this device) | K022115 | Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell Reservoir | Terumo Corp. | 2002 | — |
| +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 | K102464 | Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial… | Maquet Cardiopulmonary, AG | 2011 | Class I |
| +3 | K140774 | Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir | Terumo Cardiovascular Systems Corporation | 2014 | — |
| +2 | K132829 | Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators | Maquet Cardiopulmonary, AG | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 3 | 1 |
| 2013 | 5 | 0 |
| 2014 | 3 | 1 |
| 2015 | 4 | 0 |
| 2018 | 2 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K933586 | Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive SurfaceSummary page 3…ed use, design, technology/principles of operation, materials and specifications to the following devices: Medtronic Minimax Plus Oxygenator wiwo Hardshell Reservoir - (K933586). Cobe VPCML Plus Oxygenator with Hardshell Reservoir - (K842908). Intended Use: The CAPIOXO RX05 Hollow Fiber Oxygenator withlw… | 1994 |
| * | K842908 | Variable Prime Cobe Membrane LungSummary page 3…specifications to the following devices: Medtronic Minimax Plus Oxygenator wiwo Hardshell Reservoir - (K933586). Cobe VPCML Plus Oxygenator with Hardshell Reservoir - (K842908). Intended Use: The CAPIOXO RX05 Hollow Fiber Oxygenator withlwithout I Iardshell Reservoir is intended to be used to exchange g… | 1985 |
What descends from it? (26)
See all 268 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062381 | Capiox RX Oxygenator with or Without Reservoir | 2006 | 9 |
| K102464 | Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial Filter with… Class I | 2011 | 6 |
| K102919 | Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy… | 2011 | 1 |
| K090449 | Medos Hilite Infant Oxygenator, Model 1000, 800 LT | 2009 | 1 |
| K071572 | Capiox FX05 Hollow Fiber Oxygenator with Integrated Arterial Filter | 2007 | 1 |
| K130493 | Capiox RX05 Hollow Fiber Oxygenator/Reservoir | 2013 | 0 |
| K091062 | Medos Hilite Infant Reservoir, Model MVC 0730 | 2009 | 0 |
| K033800 | Capiox Cardiotomy Reservoir | 2004 | 0 |
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.
- K102464Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline/Bioline…Maquet Cardiopulmonary, AG · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal…Maquet Cardiopulmonary, AG · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
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 CAPIOXO RX05 Hollow Fiber Oxygenator witWwithout 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 cardiopulnioiiary bypass surgery. 'The integral heat exchanger is used to ivarrn or cool blood and/or perfusion fluid as it flows through the device. The (detachable) hardshell reservoir is used to store blood during extracorporeal circulation from…
Read the full statement (163 words)
The CAPIOXO RX05 Hollow Fiber Oxygenator witWwithout 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 cardiopulnioiiary bypass surgery.
'The integral heat exchanger is used to ivarrn or cool blood and/or perfusion fluid as it flows through the device.
The (detachable) hardshell reservoir is used to store blood during extracorporeal circulation from both venous line and the cardiotomy line (via gravity or vacuum assisted venous drainage procedurcs). 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 CAPIOXO RX05 Oxygenator witWwithout hardshell reservoir can be used in procedures lasting up to 6 hours.
The CAPIOXO RX05 is for use with neonatal and infant patients when the required blood flow rate will not exceed 1.5 L/min.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022115: Capiox RX05 Hollow Fiber Oxygenator W/Without 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/K022115
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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