510(k) · Cleared
ClearedSheridan Endobronchial Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on Nov 2, 2018 as substantially equivalent to K141888 (Teleflexmedical, Inc., 2015) after a 276-day review. Its family tree reaches back 4 generations to 1977. 1 later device descends from it.
- Decided
- Nov 2, 2018
- Review
- 276 days
- Class
- Class II
- Product code
- CBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K771219 (1977). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK771219 Broncho-CathMallinckrodt Critical Care · 1977
- 3 generations backK051522 Silbroncho Double Lumen TubeFuji Systems Corp. · 2005
- 2 generations backK092886 Well Lead Endobronchial TubesWell Lead Instruments · 2010 · Recalled
- 1 generation backK141888 Rusch Endobronchial TubesTeleflexmedical, Inc. · 2015
- This deviceK180253 Sheridan Endobronchial TubesTeleflex Medical · 2018
- Descendant · cites it directly · 0 of its ownK200968 ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39RInsung Medical Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200968ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39RInsung Medical Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K771219 | Broncho-Cath | Mallinckrodt Critical Care | 1977 | — |
| −3 | K051522 | Silbroncho Double Lumen Tube | Fuji Systems Corp. | 2005 | — |
| −2 | K092886 | Well Lead Endobronchial Tubes | Well Lead Instruments | 2010 | 1 |
| −1 | K141888 | Rusch Endobronchial Tubes | Teleflexmedical, Inc. | 2015 | — |
| 0 (this device) | K180253 | Sheridan Endobronchial Tubes | Teleflex Medical | 2018 | — |
| +1 | K200968 | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R | Insung Medical Co., Ltd. | 2020 | — |
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 |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K141888 | Rusch Endobronchial TubesSummary page 4…nchial Tube Classification Name: Tube, Tracheal/Bronchial, Differential Ventilation (w/wo connector) (Class II per 21 CFR 868.5740, Product Code CBI) Predicate Device K141888 Rusch Endobronchial Tubes Device Description The Sheridan Endobronchial Tube is a sterile, single patient use PVC Double-Lumen… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200968 | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R | 2020 | 0 |
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 41 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K200968 (Insung Medical Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
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. 2018, 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 SHERIDAN® Endobronchial Tube is intended for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The SHERIDAN® Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180253: Sheridan 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/K180253
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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