510(k) · Cleared
ClearedCapiox Cardiotomy Reservoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corporation · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Feb 10, 2004 as substantially equivalent to K022115 (Terumo Corp., 2002) and 1 other predicate after a 67-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Feb 10, 2004
- Review
- 67 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 2
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) | K033800 | Capiox Cardiotomy Reservoir | Terumo Cardiovascular Systems Corporation | 2004 | — |
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 DTN? 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 DTN device
- #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.4 · 7 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 |
|---|---|---|---|
| * | K022115 | Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell ReservoirSummary page 1…use, materials, design, technology and principles of operation, and performance to the following devices: * CAPIOX® RX05 Hardshell Reservoir (Cardiotomy Section) - K022 115. • Medtronic Minimax Hardshell Reservoir (Cardiotomy Section) - K933586. Intended Use: The CAPIOX® Cardiotomy Reservoir is d… | 2002 |
| * | K933586 | Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive SurfaceSummary page 1…nce to the following devices: * CAPIOX® RX05 Hardshell Reservoir (Cardiotomy Section) - K022 115. • Medtronic Minimax Hardshell Reservoir (Cardiotomy Section) - K933586. Intended Use: The CAPIOX® Cardiotomy Reservoir is designed to facilitate the removal of particulate matter and micro air bubble… | 1994 |
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 19 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 DTN devicesDTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTN
38in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTN
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTN
8in 2025
MAUDE reports naming product code DTN, 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 | 2 | — | 1 | 10 |
| 2008 | 1 | — | 1 | 8 |
| 2009 | 7 | 211 | 1 | 10 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 2 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 4 | 79 | 0 | 47 |
| 2014 | 3 | 38 | 0 | 52 |
| 2015 | 2 | — | 0 | 27 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 2 | — | 1 | 3 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CAPIOX® Cardiotomy Reservoir is designed to facilitate the removal of particulate matter and micro air bubbles from blood that is aspirated from the thoracic cavity and/or the left ventricle, and store it during extra corporeal circulation. The device may be used for procedures lasting up to 6 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033800: Capiox Cardiotomy Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033800
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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