510(k) · Cleared
Recalled · Class I · 2015Kendall Sher-I-Bronch Endobrochial Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kendall Healthcare Products Co. Div.Of Tyco Health · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on Jul 31, 1996 as substantially equivalent to K851856 (Sheridan Catheter Corp., 1985) and 1 other predicate after a 72-day review. Its family tree reaches back 1 generation to 1977. 2 of the 3 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times, including a Class I recall.
- Decided
- Jul 31, 1996
- Review
- 72 days
- Class
- Class II
- Product code
- CBI
- Recalls
- 2 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K771219 (1977). 2 ancestors in all. No later device cites it as a predicate yet. 2 of the 3 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK771219 Broncho-CathMallinckrodt Critical Care · 1977
- This deviceK961977 Kendall Sher-I-Bronch Endobrochial TubeKendall Healthcare Products Co. Div.Of Tyco Health · 1996
Class I recalls in this family
- K851856 Tracheal/Bronchial Differential Ventilation Tubedirect predicate · 1985
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) | K961977 | Kendall Sher-I-Bronch Endobrochial Tube | Kendall Healthcare Products Co. Div.Of Tyco Health | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K851856 | Tracheal/Bronchial Differential Ventilation TubeSummary page 1…dobronchial Tube is substantially equivalent in intended use function and composition to the commercially available Kendall SHER-I-BRONCH® Endobronchial Tube (510(k) No. K851856) and Mallinkrodt Broncho-Cath® Endobronchial Tube (510(k) No. K771219). 4, Device Description The proposed Kendall SHER-I-BRONC… | 1985 |
| * | K771219 | Broncho-CathSummary page 1…and composition to the commercially available Kendall SHER-I-BRONCH® Endobronchial Tube (510(k) No. K851856) and Mallinkrodt Broncho-Cath® Endobronchial Tube (510(k) No. K771219). 4, Device Description The proposed Kendall SHER-I-BRONCH® Endobronchial Tube is a sterile, single use device which is indicat… | 1977 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 1, 2015 | Class I | Z-2367-2015 | Unknown/Undetermined by firm | The double swivel connector may crack or separate on the endobronchial tube. |
| Sep 27, 2006 | Not classified | Z-0125-2007 | Other | Biological indicator failed. Investigation eliminated all equipment and product related factors. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K851856Tracheal/Bronchial Differential Ventilation TubeSheridan Catheter Corp. · 1985 · Direct predicate · ◆ in the 1985 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
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 endobronchial tube is intended for use in thoracic surgery, bronchospirometry, administration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
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/K961977 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961977: Kendall Sher-I-Bronch Endobrochial Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961977
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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