510(k) · Cleared
Cleared7.0 FR. Endobronchial 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 14, 2002 as substantially equivalent to K962167 (Cook, Inc., 1997) and 2 other predicates after a 64-day review. Its family tree reaches back 1 generation to 1989. 14 later devices descend from it.
- Decided
- Aug 14, 2002
- Review
- 64 days
- Class
- Class II
- Product code
- CBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K894337 (1989). 3 ancestors in all. 14 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK894337 Univent Tube 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MMVitaid, Ltd. · 1989
- This deviceK021920 7.0 FR. Endobronchial BlockerCook, Inc. · 2002
- Descendant · cites it directly · 8 of its ownK071694 Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXXDaiken Medical Co, Ltd. · 2008
- Descendant · 2 generations on · 6 of its ownK093888 Coopdech Endobronchial Blocker TubeDaiken Medical Co, Ltd. · 2010
- Descendant · 3 generations on · 3 of its ownK121028 Etview Tracheoscopic Ventilation Tube (TVT (TM))Etview, Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK083883 Chartis CatheterPulmonx, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK111522 Chartis Catheter Model CHR-CA-12.0Pulmonx, Inc. · 2011
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K071694Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXXDaiken Medical Co, Ltd. · 2008 · cites it directly8descendants
- K093888Coopdech Endobronchial Blocker TubeDaiken Medical Co, Ltd. · 2010 · 2 generations on6descendants
- K121028Etview Tracheoscopic Ventilation Tube (TVT (TM))Etview, Ltd. · 2012 · 3 generations on3descendants
- K083883Chartis CatheterPulmonx, Inc. · 2009 · cites it directly3descendants
- K111522Chartis Catheter Model CHR-CA-12.0Pulmonx, Inc. · 2011 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894337 | Univent Tube 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM | Vitaid, Ltd. | 1989 | — |
| 0 (this device) | K021920 | 7.0 FR. Endobronchial Blocker | Cook, Inc. | 2002 | — |
| +1 | K071694 | Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXX | Daiken Medical Co, Ltd. | 2008 | — |
| +2 | K093888 | Coopdech Endobronchial Blocker Tube | Daiken Medical Co, Ltd. | 2010 | — |
| +3 | K121028 | Etview Tracheoscopic Ventilation Tube (TVT (TM)) | Etview, Ltd. | 2012 | — |
| +1 | K083883 | Chartis Catheter | Pulmonx, Inc. | 2009 | — |
| +2 | K111522 | Chartis Catheter Model CHR-CA-12.0 | Pulmonx, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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 12.1 · 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? (3)
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 |
|---|---|---|---|
| * | K962167 | Bronchial BlockerSummary page 2…cedures which require one-lung ventilation. SubstantiaI Eq uivaIe nce The 7.0 Fr. Endobronchial Blocker is similar to the Cook Bronchial Blocker (D.C. #K962167), The Arndt Pediatric Endobronchial Blocker (D.C. #K002288) and the Univent Tube D.C. #K894337). The 7.0 Fr. Endobronchial Bl… | 1997 |
| * | K002288 | Arndt Pediatric Endobronchial BlockerSummary page 2…ntiaI Eq uivaIe nce The 7.0 Fr. Endobronchial Blocker is similar to the Cook Bronchial Blocker (D.C. #K962167), The Arndt Pediatric Endobronchial Blocker (D.C. #K002288) and the Univent Tube D.C. #K894337). The 7.0 Fr. Endobronchial Blocker is a modification of the Arndt Pediatric Endobron… | 2000 |
| * | K894337 | Univent Tube 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MMSummary page 2…obronchial Blocker is similar to the Cook Bronchial Blocker (D.C. #K962167), The Arndt Pediatric Endobronchial Blocker (D.C. #K002288) and the Univent Tube D.C. #K894337). The 7.0 Fr. Endobronchial Blocker is a modification of the Arndt Pediatric Endobronchial Blocker and the Cook Bronchial… | 1989 |
What descends from it? (14)
See all 145 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?
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 | — |
What is it indicated for?
The 7.0 Fr. Endobronchial Blocker is intended for use to differentially intubate a patient’s bronchus in order to isolate the left or right lung for procedures which require one lung ventilation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021920 · printed Nov 3, 2026
Cite this page
510(k) Report. “K021920: 7.0 FR. Endobronchial Blocker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021920
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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