510(k) · Cleared
ClearedSilbroncho Double Lumen Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fuji Systems Corp. · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on Aug 17, 2005 as substantially equivalent to K771219 (Mallinckrodt Critical Care, 1977) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1977. 12 later devices descend from it.
- Decided
- Aug 17, 2005
- Review
- 70 days
- Class
- Class II
- Product code
- CBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K771219 (1977). 2 ancestors in all. 12 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK771219 Broncho-CathMallinckrodt Critical Care · 1977
- This deviceK051522 Silbroncho Double Lumen TubeFuji Systems Corp. · 2005
- Descendant · cites it directly · 10 of its ownK092886 Well Lead Endobronchial TubesWell Lead Instruments · 2010 · Recalled
- Descendant · 2 generations on · 4 of its ownK113576 Double Lumen Video Tracheosdope (DLVT) SystemEtview, Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK123853 Vivasight-DL SystemEtview, Ltd. · 2013
- Descendant · 2 generations on · 2 of its ownK181886 VivaSight-DL SystemEtview, Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK141888 Rusch Endobronchial TubesTeleflexmedical, Inc. · 2015
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K092886Well Lead Endobronchial TubesWell Lead Instruments · 2010 · cites it directly10descendants
- K113576Double Lumen Video Tracheosdope (DLVT) SystemEtview, Ltd. · 2012 · 2 generations on4descendants
- K123853Vivasight-DL SystemEtview, Ltd. · 2013 · cites it directly3descendants
- K181886VivaSight-DL SystemEtview, Ltd. · 2018 · 2 generations on2descendants
- K141888Rusch Endobronchial TubesTeleflexmedical, Inc. · 2015 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771219 | Broncho-Cath | Mallinckrodt Critical Care | 1977 | — |
| 0 (this device) | K051522 | Silbroncho Double Lumen Tube | Fuji Systems Corp. | 2005 | — |
| +1 | K092886 | Well Lead Endobronchial Tubes | Well Lead Instruments | 2010 | 1 |
| +2 | K113576 | Double Lumen Video Tracheosdope (DLVT) System | Etview, Ltd. | 2012 | — |
| +1 | K123853 | Vivasight-DL System | Etview, Ltd. | 2013 | — |
| +2 | K181886 | VivaSight-DL System | Etview, Ltd. | 2018 | — |
| +1 | K141888 | Rusch Endobronchial Tubes | Teleflexmedical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K771219 | Broncho-CathSummary page 1…without connectors Predicate Devices: Mallinckrodt Broncho-Cath - K771219 Vitaid wire reinforced ET tube - K932647 Device Description: Th… | 1977 |
| * | K932647 | Wire Reinforced Endotracheal TubeSummary page 1…Mallinckrodt Broncho-Cath - K771219 Vitaid wire reinforced ET tube - K932647 Device Description: The Silbroncho® double lumen tube is made of silicone and is available in sizes 33 to 39 French. They ar… | 1993 |
What descends from it? (12)
See all 124 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 Silbroncho® is used to isolate the left or the 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/K051522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051522: Silbroncho Double Lumen Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051522
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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