510(k) · Cleared
Recalled · Class II · 2016Well Lead Endobronchial Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Lead Instruments · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on Mar 11, 2010 as substantially equivalent to K771219 (Mallinckrodt Critical Care, 1977) and 1 other predicate after a 171-day review. Its family tree reaches back 2 generations to 1977. 10 later devices descend from it. It has been recalled once.
- Decided
- Mar 11, 2010
- Review
- 171 days
- Class
- Class II
- Product code
- CBI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K771219 (1977). 3 ancestors in all. 10 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK771219 Broncho-CathMallinckrodt Critical Care · 1977
- 1 generation backK051522 Silbroncho Double Lumen TubeFuji Systems Corp. · 2005
- This deviceK092886 Well Lead Endobronchial TubesWell Lead Instruments · 2010
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 1 of its ownK203749 Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter CableAmbu A/S · 2021 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K113576Double Lumen Video Tracheosdope (DLVT) SystemEtview, Ltd. · 2012 · cites it directly4descendants
- K123853Vivasight-DL SystemEtview, Ltd. · 2013 · cites it directly3descendants
- K181886VivaSight-DL SystemEtview, Ltd. · 2018 · 2 generations on2descendants
- K141888Rusch Endobronchial TubesTeleflexmedical, Inc. · 2015 · cites it directly2descendants
- K203749Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter CableAmbu A/S · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771219 | Broncho-Cath | Mallinckrodt Critical Care | 1977 | — |
| −1 | K051522 | Silbroncho Double Lumen Tube | Fuji Systems Corp. | 2005 | — |
| 0 (this device) | K092886 | Well Lead Endobronchial Tubes | Well Lead Instruments | 2010 | — |
| +1 | 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 | — |
| +3 | K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable | Ambu A/S | 2021 | 2 |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 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…opaque line that runs through the tube making them detectable by x-ray. Predicate Device: K77 1219 - Mallinckrodt Bronch-Cath KO051522 - Fuji Double Lumen Bronch Tube Substantial E… | 1977 |
| * | K051522 | Silbroncho Double Lumen TubeSummary page 1…e making them detectable by x-ray. Predicate Device: K77 1219 - Mallinckrodt Bronch-Cath KO051522 - Fuji Double Lumen Bronch Tube Substantial Equivalence: Well Lead Medical Instruments claims the proposed… | 2005 |
What descends from it? (10)
5 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2016 | Class II | Z-1399-2017 | Under Investigation by firm | The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 28.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K113576 (Etview, Ltd., 2012) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K771219.
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 Well Lead Endobronchial Tube 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/K092886 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092886: Well Lead Endobronchial Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092886
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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