510(k) · Cleared
ClearedCapiox (R) Bubble Trap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · KRL Detector, Bubble, Cardiopulmonary Bypass
Cleared on Jul 9, 1991 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Jul 9, 1991
- Review
- 89 days
- Class
- Class II
- Product code
- KRL
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK911632 Capiox (R) Bubble TrapTerumo Medical Corp. · 1991
- Descendant · cites it directly · 0 of its ownK090698 Capiox Bubble Trap with X-CoatingTerumo Cardiovascular Systems · 2009
- Descendant · cites it directly · 0 of its ownK082412 Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline…Mapquet Cardiopulmonary AG · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911632 | Capiox (R) Bubble Trap | Terumo Medical Corp. | 1991 | — |
| +1 | K090698 | Capiox Bubble Trap with X-Coating | Terumo Cardiovascular Systems | 2009 | — |
| +1 | K082412 | Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating… | Mapquet Cardiopulmonary AG | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 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 KRL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (2)
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?
- Of its descendants, K090698 (Terumo Cardiovascular Systems, 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KRL devicesKRL Detector, Bubble, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRL
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KRL
Too few KRL 510(k)s in any year since 2007 to give a median.
Recalls per year · KRL
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRL
4in 2024
MAUDE reports naming product code KRL, 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 | 1 | — | 3 | 10 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 1 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K911632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911632: Capiox (R) Bubble Trap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911632
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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