510(k) · Cleared
ClearedEndobronchial Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Henan Tuoren Medical Device Co., Ltd. · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on Jun 10, 2016 as substantially equivalent to K092886 (Well Lead Instruments, 2010) after a 305-day review. Its family tree reaches back 3 generations to 1977.
- Decided
- Jun 10, 2016
- Review
- 305 days
- Class
- Class II
- Product code
- CBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K771219 (1977). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK771219 Broncho-CathMallinckrodt Critical Care · 1977
- 2 generations backK051522 Silbroncho Double Lumen TubeFuji Systems Corp. · 2005
- 1 generation backK092886 Well Lead Endobronchial TubesWell Lead Instruments · 2010 · Recalled
- This deviceK152251 Endobronchial TubeHenan Tuoren Medical Device Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K771219 | Broncho-Cath | Mallinckrodt Critical Care | 1977 | — |
| −2 | K051522 | Silbroncho Double Lumen Tube | Fuji Systems Corp. | 2005 | — |
| −1 | K092886 | Well Lead Endobronchial Tubes | Well Lead Instruments | 2010 | 1 |
| 0 (this device) | K152251 | Endobronchial Tube | Henan Tuoren Medical Device Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 |
|---|---|---|---|
| * | K092886 | Well Lead Endobronchial TubesSummary page 5…Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. 5. Predicate Device Well LEAD Endobronchial Tubes(K092886) 6. Device Description The Endobronchial Tube is made of Polyvinylchloride and is available in sizes 26fr to 41fr. They are des… | 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 39 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 4 other devices also cite its predicate K092886.
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. 2016, 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 Endobronchial 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/K152251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152251: Endobronchial Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152251
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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