510(k) · Cleared
ClearedCapiox FX Hollow Fiber Oxygenator W/ 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 K071572 (Terumo Corp., 2007) after a 36-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Mar 13, 2013
- Review
- 36 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K943917 (1995). 6 ancestors in all, the oldest K842908 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK943917 Capiox Arterial FilterTerumo Medical Corp. · 1995
- 2 generations backK011804 Capiox Arterial Filter with X-Coating, Product Code CX*AFO2XTerumo Cardiovascular Systems Corp. · 2001
- 1 generation backK071572 Capiox FX05 Hollow Fiber Oxygenator with Integrated Arterial FilterTerumo Corp. · 2007
- This deviceK130280 Capiox FX Hollow Fiber Oxygenator W/ ReservoirTerumo Corporation · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943917 | Capiox Arterial Filter | Terumo Medical Corp. | 1995 | — |
| −2 | K011804 | Capiox Arterial Filter with X-Coating, Product Code CX*AFO2X | Terumo Cardiovascular Systems Corp. | 2001 | — |
| −1 | K071572 | Capiox FX05 Hollow Fiber Oxygenator with Integrated Arterial Filter | Terumo Corp. | 2007 | — |
| 0 (this device) | K130280 | Capiox FX Hollow Fiber Oxygenator W/ Reservoir | Terumo Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1994 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K071572 | Capiox FX05 Hollow Fiber Oxygenator with Integrated Arterial FilterSummary page 2…ent in intended use, design, technology/principles of operation, materials and specifications to the following devices: Terumno's Capiox® FX05 Oxygenator/Reservoir - K071 572. 24… | 2007 |
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 18 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- None of the 6 ancestors has a recall.
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 Capiox FX05 device is intended to be used during open heart surgical procedures to transfer oxygen and remove carbon dioxide from blood and to control the blood temperature during cardiopulmonary bypass for periods up to 6 hours. The Capiox FX05 is a Neonate/Infant oxygenator intended for use in procedures up to a maximum flow of 1.5 L/min. The patient weight and BSA should be considered upon use.
The FX05 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures.
The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130280: Capiox FX Hollow Fiber Oxygenator W/ Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130280
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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