510(k) · Cleared
ClearedCapiox SX Hardshell Reservoir with X-Coating
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 Aug 22, 2000 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 22, 2000
- Review
- 29 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK002238 Capiox SX Hardshell Reservoir with X-CoatingTerumo Cardiovascular Systems Corp. · 2000
- Descendant · cites it directly · 4 of its ownK013526 Capiox RX Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2001
- Descendant · 2 generations on · 2 of its ownK130359 Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell…Terumo Cardiovascular Systems Corp. · 2013
- Descendant · 3 generations on · 0 of its ownK153143 Capiox Advance Hardshell ReservoirTerumo Cardiovascular Systems Corporation · 2015
- Descendant · 3 generations on · 0 of its ownK153140 Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox…Terumo Cardiovascular Systems Corp. · 2015
- Descendant · 2 generations on · 0 of its ownK030505 Capiox Cardiotomy ReservoirTerumo Cardiovascular Systems Corp. · 2003
Most influential descendants
Showing 5 of 5 · See all- K013526Capiox RX Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2001 · cites it directly4descendants
- K130359Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir, Capiox SX25…Terumo Cardiovascular Systems Corp. · 2013 · 2 generations on2descendants
- K153143Capiox Advance Hardshell ReservoirTerumo Cardiovascular Systems Corporation · 2015 · 3 generations on0descendants
- K153140Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/…Terumo Cardiovascular Systems Corp. · 2015 · 3 generations on0descendants
- K030505Capiox Cardiotomy ReservoirTerumo Cardiovascular Systems Corp. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002238 | Capiox SX Hardshell Reservoir with X-Coating | Terumo Cardiovascular Systems Corp. | 2000 | — |
| +1 | K013526 | Capiox RX Hardshell Reservoir | Terumo Cardiovascular Systems Corp. | 2001 | — |
| +2 | K130359 | Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir… | Terumo Cardiovascular Systems Corp. | 2013 | — |
| +3 | K153143 | Capiox Advance Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015 | — |
| +3 | K153140 | Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18… | Terumo Cardiovascular Systems Corp. | 2015 | — |
| +2 | K030505 | Capiox Cardiotomy Reservoir | Terumo Cardiovascular Systems Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013526 | Capiox RX Hardshell Reservoir | 2001 | 4 |
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?
- Of its descendants, K013526 (Terumo Cardiovascular Systems Corp., 2001) has gone furthest, with 4 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 | — |
https://510kreport.com/device/K002238 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002238: Capiox SX Hardshell Reservoir with X-Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002238
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026