510(k) · Cleared
Recalled · Class I · 2019Tracheal/Bronchial Differential Ventilation Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sheridan Catheter Corp. · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on May 23, 1985 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 2 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 4 times, including a Class I recall.
- Decided
- May 23, 1985
- Review
- 27 days
- Class
- Class II
- Product code
- CBI
- Recalls
- 4 (1 Class I)
- Predicates
- 0
1 later device descends from it, 1 citing it directly. 2 of the 2 devices in this family, counting this one, have a Class I recall.
- This deviceK851856 Tracheal/Bronchial Differential Ventilation TubeSheridan Catheter Corp. · 1985
- Descendant · cites it directly · 0 of its ownK961977 Kendall Sher-I-Bronch Endobrochial TubeKendall Healthcare Products Co. Div.Of Tyco Health · 1996 · Recalled (Class I)
Class I recalls in this family
- K961977 Kendall Sher-I-Bronch Endobrochial Tubecites it directly · 1996
Most influential descendants
Showing 1 of 1 · See all- K961977Kendall Sher-I-Bronch Endobrochial TubeKendall Healthcare Products Co. Div.Of Tyco Health · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K851856 | Tracheal/Bronchial Differential Ventilation Tube | Sheridan Catheter Corp. | 1985 | — |
| +1 | K961977 | Kendall Sher-I-Bronch Endobrochial Tube | Kendall Healthcare Products Co. Div.Of Tyco Health | 1996 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K961977 | Kendall Sher-I-Bronch Endobrochial Tube Class I | 1996 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2019 | Class II | Z-0703-2020 | Process control | The tracheal and brochial swivel connectors are incorrectly labeled. |
| Jun 1, 2015 | Class I | Z-2368-2015 | Unknown/Undetermined by firm | The double swivel connector may crack or separate on the endobronchial tube. |
| Feb 23, 2005 | Not classified | Z-0680-05 | Other | The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and catalog number 5-16137 stating 'Bronchial - Left' instead of 'Bronchial -… |
| Feb 23, 2005 | Not classified | Z-0681-05 | Other | The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and catalog number 5-16137 stating 'Bronchial - Left' instead of 'Bronchial -… |
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.
- K961977Kendall Sher-I-Bronch Endobrochial TubeKendall Healthcare Products Co. Div.Of Tyco Health · 1996 · Cites it directly · ◆ in the 1996 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K961977 (Kendall Healthcare Products Co. Div.Of Tyco Health, 1996) 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.
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 | — |
https://510kreport.com/device/K851856 · printed Nov 5, 2026
Cite this page
510(k) Report. “K851856: Tracheal/Bronchial Differential Ventilation Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K851856
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026