510(k) · Cleared
ClearedBroncho-Cath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Critical Care · BTS Tube, Bronchial (W/Wo Connector)
Cleared on Aug 4, 1977 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 15 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.
- Decided
- Aug 4, 1977
- Review
- 30 days
- Class
- Class II
- Product code
- BTS
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- This deviceK771219 Broncho-CathMallinckrodt Critical Care · 1977
- Descendant · cites it directly · 12 of its ownK051522 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 · 2 generations on · 3 of its ownK123853 Vivasight-DL SystemEtview, Ltd. · 2013
- Descendant · 3 generations on · 2 of its ownK181886 VivaSight-DL SystemEtview, Ltd. · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K961977 Kendall Sher-I-Bronch Endobrochial Tubecites it directly · 1996
Most influential descendants
Showing 5 of 14 · See all- K051522Silbroncho Double Lumen TubeFuji Systems Corp. · 2005 · cites it directly12descendants
- 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 · 2 generations on3descendants
- K181886VivaSight-DL SystemEtview, Ltd. · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K771219 | Broncho-Cath | Mallinckrodt Critical Care | 1977 | — |
| +1 | 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 | — |
| +2 | K123853 | Vivasight-DL System | Etview, Ltd. | 2013 | — |
| +3 | K181886 | VivaSight-DL System | Etview, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 1 |
| 2005 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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, K051522 (Fuji Systems Corp., 2005) has gone furthest, with 12 descendants of its own.
How does its category compare?
All BTS devicesBTS Tube, Bronchial (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTS
FDA has decided no BTS device since 2007.
Median 510(k) review, days · BTS
Too few BTS 510(k)s in any year since 2007 to give a median.
Recalls per year · BTS
No recall names BTS since 2007.
Adverse event reports per year · BTS
204in 2025
MAUDE reports naming product code BTS, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 29 |
| 2012 | 0 | — | 0 | 89 |
| 2013 | 0 | — | 0 | 116 |
| 2014 | 0 | — | 0 | 228 |
| 2015 | 0 | — | 0 | 312 |
| 2016 | 0 | — | 0 | 226 |
| 2017 | 0 | — | 0 | 190 |
| 2018 | 0 | — | 0 | 124 |
| 2019 | 0 | — | 0 | 122 |
| 2020 | 0 | — | 0 | 91 |
| 2021 | 0 | — | 0 | 110 |
| 2022 | 0 | — | 0 | 140 |
| 2023 | 0 | — | 0 | 162 |
| 2024 | 0 | — | 0 | 172 |
| 2025 | 0 | — | 0 | 204 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K771219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K771219: Broncho-Cath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K771219
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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