510(k) · Cleared
ClearedCapiox RX Hardshell Reservoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Nov 15, 2001 as substantially equivalent to K002238 (Terumo Cardiovascular Systems Corp., 2000) after a 23-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Nov 15, 2001
- Review
- 23 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002238 (2000). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002238 Capiox SX Hardshell Reservoir with X-CoatingTerumo Cardiovascular Systems Corp. · 2000
- This deviceK013526 Capiox RX Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2001
- Descendant · cites it directly · 2 of its ownK130359 Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell…Terumo Cardiovascular Systems Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK153143 Capiox Advance Hardshell ReservoirTerumo Cardiovascular Systems Corporation · 2015
- Descendant · 2 generations on · 0 of its ownK153140 Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox…Terumo Cardiovascular Systems Corp. · 2015
- Descendant · cites it directly · 0 of its ownK030505 Capiox Cardiotomy ReservoirTerumo Cardiovascular Systems Corp. · 2003
Most influential descendants
Showing 4 of 4 · See all- K130359Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir, Capiox SX25…Terumo Cardiovascular Systems Corp. · 2013 · cites it directly2descendants
- K153143Capiox Advance Hardshell ReservoirTerumo Cardiovascular Systems Corporation · 2015 · 2 generations on0descendants
- K153140Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/…Terumo Cardiovascular Systems Corp. · 2015 · 2 generations on0descendants
- K030505Capiox Cardiotomy ReservoirTerumo Cardiovascular Systems Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002238 | Capiox SX Hardshell Reservoir with X-Coating | Terumo Cardiovascular Systems Corp. | 2000 | — |
| 0 (this device) | K013526 | Capiox RX Hardshell Reservoir | Terumo Cardiovascular Systems Corp. | 2001 | — |
| +1 | K130359 | Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir… | Terumo Cardiovascular Systems Corp. | 2013 | — |
| +2 | K153143 | Capiox Advance Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015 | — |
| +2 | K153140 | Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18… | Terumo Cardiovascular Systems Corp. | 2015 | — |
| +1 | K030505 | Capiox Cardiotomy Reservoir | Terumo Cardiovascular Systems Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 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? (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 |
|---|---|---|---|
| * | K002238 | Capiox SX Hardshell Reservoir with X-CoatingSummary page 1…Reservoir is substantially equivalent in intended use, materials, design, technology and principles of operation, and performance to the CAPIOX® SX Hardshell Reservoir (K002238). Intended Use: The CAPIOX® RX Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulati… | 2000 |
What descends from it? (4)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K130359 (Terumo Cardiovascular Systems Corp., 2013) has gone furthest, with 2 descendants of its own.
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® RX Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal. The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return blood to the patient for blood volume replacement. The…
Read the full statement (109 words)
The CAPIOX® RX Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.
The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return blood to the patient for blood volume replacement.
The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass.
The Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device.
The device may be used for procedures lasting up to 6 hours
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013526 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013526: Capiox RX Hardshell Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013526
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026