510(k) · Cleared
ClearedCoopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Daiken Medical Co, Ltd. · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on Mar 20, 2008 as substantially equivalent to K021920 (Cook, Inc., 2002) and 1 other predicate after a 274-day review. Its family tree reaches back 2 generations to 1997. 8 later devices descend from it.
- Decided
- Mar 20, 2008
- Review
- 274 days
- Class
- Class II
- Product code
- CBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962167 (1997). 5 ancestors in all, the oldest K894337 (1989). 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK962167 Bronchial BlockerCook, Inc. · 1997
- 1 generation backK013865 Tip Deflrcting Endobronchial BlockerCook, Inc. · 2002
- This deviceK071694 Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXXDaiken Medical Co, Ltd. · 2008
- Descendant · cites it directly · 6 of its ownK093888 Coopdech Endobronchial Blocker TubeDaiken Medical Co, Ltd. · 2010
- Descendant · 2 generations on · 3 of its ownK121028 Etview Tracheoscopic Ventilation Tube (TVT (TM))Etview, Ltd. · 2012
- Descendant · 3 generations on · 1 of its ownK152438 ETView VivaSight-SL (TVT) systemEtview, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK251950 Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube…Hangzhou Tappa Medical Technology Co., Ltd. · 2026
- Descendant · 4 generations on · 0 of its ownK250243 ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5)…Flexicare Medical Limited. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K093888Coopdech Endobronchial Blocker TubeDaiken Medical Co, Ltd. · 2010 · cites it directly6descendants
- K121028Etview Tracheoscopic Ventilation Tube (TVT (TM))Etview, Ltd. · 2012 · 2 generations on3descendants
- K152438ETView VivaSight-SL (TVT) systemEtview, Ltd. · 2016 · 3 generations on1descendant
- K251950Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107)…Hangzhou Tappa Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu…Flexicare Medical Limited. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962167 | Bronchial Blocker | Cook, Inc. | 1997 | — |
| −1 | K013865 | Tip Deflrcting Endobronchial Blocker | Cook, Inc. | 2002 | — |
| 0 (this device) | K071694 | Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXX | Daiken Medical Co, Ltd. | 2008 | — |
| +1 | K093888 | Coopdech Endobronchial Blocker Tube | Daiken Medical Co, Ltd. | 2010 | — |
| +2 | K121028 | Etview Tracheoscopic Ventilation Tube (TVT (TM)) | Etview, Ltd. | 2012 | — |
| +3 | K152438 | ETView VivaSight-SL (TVT) system | Etview, Ltd. | 2016 | — |
| +2 | K251950 | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107)… | Hangzhou Tappa Medical Technology Co., Ltd. | 2026 | — |
| +4 | K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5)… | Flexicare Medical Limited. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 12.0 · 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? (2)
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 |
|---|---|---|---|
| * | K021920 | 7.0 FR. Endobronchial BlockerSummary page 1…sification Name: Tube, Tracheal/bronchial, differential ventilation (w/wo connector) Predicate Device or Legally Marketed Devices: Cook "7.0 Fr. Endobronchial Blocker" (k02 1920) Cook "Tip Deflecting Endobronchial Blocker" (kO 13865) Device Description: The "Coopdech Endobronchial Blocker Tube" consists o… | 2002 |
| * | K013865 | Tip Deflrcting Endobronchial BlockerSummary page 1…al Blocker" (k021920). Testing element's to verify the design of the Coopdech Endobronchial Blocker Tube are the same as the Cook "Tip Deflecting Endobronchial Blocker" (k013865) indicating the same design features between the two products. The gas barrier property of the "Coopdech Endobronchial Blocker Tu… | 2002 |
What descends from it? (8)
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K093888 (Daiken Medical Co, Ltd., 2010) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K021920.
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. 2008, this device’s year, is highlighted.
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 COOPDECH Endobronchial Blocker Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071694 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071694: Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071694
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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