510(k) · Cleared
ClearedCapiox RX05 Hollow Fiber Oxygenator/Reservoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Corporation · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Mar 13, 2013 as substantially equivalent to K022115 (Terumo Corp., 2002) after a 15-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Mar 13, 2013
- Review
- 15 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K842908 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K842908 | Variable Prime Cobe Membrane Lung | Cobe Laboratories, Inc. | 1985 | — |
| −1 | K022115 | Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell Reservoir | Terumo Corp. | 2002 | — |
| 0 (this device) | K130493 | Capiox RX05 Hollow Fiber Oxygenator/Reservoir | Terumo Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (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 |
|---|---|---|---|
| * | K022115 | Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell ReservoirSummary page 2…to thle following devices: TerumIIo'S Capiox® RX05 Oxygenator/Reservoir - K022 115. 26… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 17.7 years on median.
- None of the 3 ancestors has a recall.
- 7 other devices also cite its predicate K022115.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 Capioxi RXO5 Hollow Fiber Oxygenator/Reservoiz device is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonaty bypass surgery. The integral heat exchanger is used to warmn or cool blood and/or perfusion fluid as it flows through the device. The (detachable) hardshiell reservoir is used to store blood during extracorporeal circulation from both the venous…
Read the full statement (158 words)
The Capioxi RXO5 Hollow Fiber Oxygenator/Reservoiz device is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonaty bypass surgery.
The integral heat exchanger is used to warmn or cool blood and/or perfusion fluid as it flows through the device.
The (detachable) hardshiell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line (via gravity or vacuumi assisted venous drainage procedures). The reservoir contains a venous section that is comprised of a Filter and defoamner to faicilitate air bubble removal. The cardiotony section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal.
The Capiox,& RXOS Oxygenator/Reservoir can be used( in procedures lasting uip to 6 hours. The Capiox RX05 is for use wvith neonatal and infantl patients when the required blood flowv rate will not exceed l.SL/Ain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130493 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130493: Capiox RX05 Hollow Fiber Oxygenator/Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130493
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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