510(k) · Cleared
ClearedCoopdech Endobronchial Blocker Tube
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 16, 2010 as substantially equivalent to K071694 (Daiken Medical Co, Ltd., 2008) after an 88-day review. Its family tree reaches back 3 generations to 1997. 6 later devices descend from it.
- Decided
- Mar 16, 2010
- Review
- 88 days
- Class
- Class II
- Product code
- CBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962167 (1997). 6 ancestors in all, the oldest K894337 (1989). 6 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK962167 Bronchial BlockerCook, Inc. · 1997
- 2 generations backK013865 Tip Deflrcting Endobronchial BlockerCook, Inc. · 2002
- 1 generation backK071694 Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXXDaiken Medical Co, Ltd. · 2008
- This deviceK093888 Coopdech Endobronchial Blocker TubeDaiken Medical Co, Ltd. · 2010
- Descendant · cites it directly · 3 of its ownK121028 Etview Tracheoscopic Ventilation Tube (TVT (TM))Etview, Ltd. · 2012
- Descendant · 2 generations on · 1 of its ownK152438 ETView VivaSight-SL (TVT) systemEtview, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK251950 Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube…Hangzhou Tappa Medical Technology Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK250243 ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5)…Flexicare Medical Limited. · 2025
- Descendant · cites it directly · 0 of its ownK232580 Disposable Endobronchial Blocker TubeShenzhen Insighters Medical Technology Co., Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K121028Etview Tracheoscopic Ventilation Tube (TVT (TM))Etview, Ltd. · 2012 · cites it directly3descendants
- K152438ETView VivaSight-SL (TVT) systemEtview, Ltd. · 2016 · 2 generations on1descendant
- K251950Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107)…Hangzhou Tappa Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
- K250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu…Flexicare Medical Limited. · 2025 · 3 generations on0descendants
- K232580Disposable Endobronchial Blocker TubeShenzhen Insighters Medical Technology Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962167 | Bronchial Blocker | Cook, Inc. | 1997 | — |
| −2 | K013865 | Tip Deflrcting Endobronchial Blocker | Cook, Inc. | 2002 | — |
| −1 | K071694 | Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXX | Daiken Medical Co, Ltd. | 2008 | — |
| 0 (this device) | K093888 | Coopdech Endobronchial Blocker Tube | Daiken Medical Co, Ltd. | 2010 | — |
| +1 | K121028 | Etview Tracheoscopic Ventilation Tube (TVT (TM)) | Etview, Ltd. | 2012 | — |
| +2 | K152438 | ETView VivaSight-SL (TVT) system | Etview, Ltd. | 2016 | — |
| +1 | K251950 | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107)… | Hangzhou Tappa Medical Technology Co., Ltd. | 2026 | — |
| +3 | K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5)… | Flexicare Medical Limited. | 2025 | — |
| +1 | K232580 | Disposable Endobronchial Blocker Tube | Shenzhen Insighters Medical Technology Co., Ltd. | 2023 | — |
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 |
|---|---|---|
| 2012 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K071694 | Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXXSummary page 2…UBE is substantially equivalent to the followinh legally marketed devices: The same trade name with the device for the application; 5 10(k): k071694 Trade name: COOPDECH ENDOBRONCHIAL BLOCKER TUBE Product code: CBI Because the same device name… | 2008 |
What descends from it? (6)
3 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 13 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K121028 (Etview, Ltd., 2012) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K071694.
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. 2010, 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.
Patient Population: Patients requiring one lung isolation.
Environment of Use: Hospitals-OR and ICU.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093888: Coopdech Endobronchial Blocker Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093888
Report an extraction error
Are you the manufacturer?
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