510(k) · Cleared
ClearedBronchial Blocker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on Aug 29, 1997 after a 450-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.
- Decided
- Aug 29, 1997
- Review
- 450 days
- Class
- Class II
- Product code
- CBI
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 3 citing it directly.
- This deviceK962167 Bronchial BlockerCook, Inc. · 1997
- Descendant · cites it directly · 14 of its ownK021920 7.0 FR. Endobronchial BlockerCook, Inc. · 2002
- Descendant · cites it directly · 9 of its ownK013865 Tip Deflrcting Endobronchial BlockerCook, Inc. · 2002
- Descendant · 2 generations on · 8 of its ownK071694 Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXXDaiken Medical Co, Ltd. · 2008
- Descendant · 3 generations on · 6 of its ownK093888 Coopdech Endobronchial Blocker TubeDaiken Medical Co, Ltd. · 2010
- Descendant · 4 generations on · 3 of its ownK121028 Etview Tracheoscopic Ventilation Tube (TVT (TM))Etview, Ltd. · 2012
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K0219207.0 FR. Endobronchial BlockerCook, Inc. · 2002 · cites it directly14descendants
- K013865Tip Deflrcting Endobronchial BlockerCook, Inc. · 2002 · cites it directly9descendants
- K071694Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXXDaiken Medical Co, Ltd. · 2008 · 2 generations on8descendants
- K093888Coopdech Endobronchial Blocker TubeDaiken Medical Co, Ltd. · 2010 · 3 generations on6descendants
- K121028Etview Tracheoscopic Ventilation Tube (TVT (TM))Etview, Ltd. · 2012 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962167 | Bronchial Blocker | Cook, Inc. | 1997 | — |
| +1 | K021920 | 7.0 FR. Endobronchial Blocker | Cook, Inc. | 2002 | — |
| +1 | K013865 | Tip Deflrcting Endobronchial Blocker | Cook, Inc. | 2002 | — |
| +2 | K071694 | Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXX | Daiken Medical Co, Ltd. | 2008 | — |
| +3 | K093888 | Coopdech Endobronchial Blocker Tube | Daiken Medical Co, Ltd. | 2010 | — |
| +4 | K121028 | Etview Tracheoscopic Ventilation Tube (TVT (TM)) | Etview, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 CBI? 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 CBI device
- #1 K253096 Chartis Precision Catheterscore 12.0 · 5 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? (17)
See all 173 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, K021920 (Cook, Inc., 2002) has gone furthest, with 14 descendants of its own.
How does its category compare?
All CBI devicesCBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CBI
134in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CBI
83in 2025
MAUDE reports naming product code CBI, 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 | 0 | — | 0 | 11 |
| 2008 | 1 | — | 0 | 16 |
| 2009 | 1 | — | 0 | 26 |
| 2010 | 2 | — | 0 | 25 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 3 | 134 | 0 | 23 |
| 2013 | 1 | — | 0 | 26 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 29 |
| 2017 | 0 | — | 0 | 61 |
| 2018 | 2 | — | 0 | 66 |
| 2019 | 0 | — | 1 | 94 |
| 2020 | 1 | — | 0 | 87 |
| 2021 | 2 | — | 0 | 159 |
| 2022 | 1 | — | 0 | 127 |
| 2023 | 1 | — | 0 | 95 |
| 2024 | 1 | — | 1 | 75 |
| 2025 | 0 | — | 0 | 83 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K962167 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962167: Bronchial Blocker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962167
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026