510(k) · Cleared
ClearedDisposable Endobronchial Blocker Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Insighters Medical Technology Co., Ltd. · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on Dec 14, 2023 as substantially equivalent to K093888 (Daiken Medical Co, Ltd., 2010) after a 111-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Dec 14, 2023
- Review
- 111 days
- Class
- Class II
- Product code
- CBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K962167 (1997). 7 ancestors in all, the oldest K894337 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK962167 Bronchial BlockerCook, Inc. · 1997
- 3 generations backK013865 Tip Deflrcting Endobronchial BlockerCook, Inc. · 2002
- 2 generations backK071694 Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXXDaiken Medical Co, Ltd. · 2008
- 1 generation backK093888 Coopdech Endobronchial Blocker TubeDaiken Medical Co, Ltd. · 2010
- This deviceK232580 Disposable Endobronchial Blocker TubeShenzhen Insighters Medical Technology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962167 | Bronchial Blocker | Cook, Inc. | 1997 | — |
| −3 | K013865 | Tip Deflrcting Endobronchial Blocker | Cook, Inc. | 2002 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K093888 | Coopdech Endobronchial Blocker TubeSummary page 6…ation Tube Classification: Ⅱ Classification Name: Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Product Code: CBI 4. Predicate Device K093888— COOPDECH ENDOBRONCHIAL BLOCKER TUBE 5. Indications for Use The Disposable Endobronchial Blocker Tube is intended to differ… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K093888.
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. 2023, 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 Disposable Endobronchial Blocker Tube is intended to differentially intubate a patient’s bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The SFr Endobronchial Blocker Tube is indicated for infants populations; The 7Fr Endobronchial Blocker Tube is indicated for children populations; The 9Fr Endobronchial Blocker Tube is indicated for adults use only.
Patient Population: Patients requiring one lung isolation.
Environment of Use: Hospitals-OR and ICU.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232580: Disposable 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/K232580
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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