510(k) · Cleared
ClearedWire Reinforced Endotracheal Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitaid, Ltd. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Nov 2, 1993 after a 153-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 13 later devices descend from it.
- Decided
- Nov 2, 1993
- Review
- 153 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly.
- This deviceK932647 Wire Reinforced Endotracheal TubeVitaid, Ltd. · 1993
- Descendant · cites it directly · 12 of its ownK051522 Silbroncho Double Lumen TubeFuji Systems Corp. · 2005
- Descendant · 2 generations on · 10 of its ownK092886 Well Lead Endobronchial TubesWell Lead Instruments · 2010 · Recalled
- Descendant · 3 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 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K051522Silbroncho Double Lumen TubeFuji Systems Corp. · 2005 · cites it directly12descendants
- K092886Well Lead Endobronchial TubesWell Lead Instruments · 2010 · 2 generations on10descendants
- K113576Double Lumen Video Tracheosdope (DLVT) SystemEtview, Ltd. · 2012 · 3 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) | K932647 | Wire Reinforced Endotracheal Tube | Vitaid, Ltd. | 1993 | — |
| +1 | K051522 | Silbroncho Double Lumen Tube | Fuji Systems Corp. | 2005 | — |
| +2 | K092886 | Well Lead Endobronchial Tubes | Well Lead Instruments | 2010 | 1 |
| +3 | 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 |
|---|---|---|
| 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.
Planning a device in BTR? 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 BTR device
- #1 K251794 Tenax® Laser Resistant Endotracheal Tubescore 12.6 · 3 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051522 | Silbroncho Double Lumen Tube | 2005 | 12 |
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?
- Of its descendants, K051522 (Fuji Systems Corp., 2005) has gone furthest, with 12 descendants of its own.
How does its category compare?
All BTR devicesBTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTR
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 2025
MAUDE reports naming product code BTR, 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 | 1 | — | 2 | 136 |
| 2008 | 7 | 61 | 0 | 169 |
| 2009 | 7 | 135 | 21 | 155 |
| 2010 | 3 | 179 | 0 | 335 |
| 2011 | 2 | — | 0 | 422 |
| 2012 | 5 | 261 | 0 | 511 |
| 2013 | 1 | — | 0 | 807 |
| 2014 | 3 | 308 | 20 (19) | 985 |
| 2015 | 3 | 262 | 0 | 1,016 |
| 2016 | 1 | — | 1 | 836 |
| 2017 | 2 | — | 0 | 812 |
| 2018 | 5 | 242 | 0 | 977 |
| 2019 | 5 | 211 | 0 | 1,379 |
| 2020 | 3 | 246 | 1 (1) | 1,070 |
| 2021 | 1 | — | 2 | 1,329 |
| 2022 | 1 | — | 3 | 1,132 |
| 2023 | 1 | — | 0 | 1,330 |
| 2024 | 1 | — | 0 | 1,678 |
| 2025 | 7 | 258 | 0 | 1,799 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K932647 · printed Nov 5, 2026
Cite this page
510(k) Report. “K932647: Wire Reinforced Endotracheal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K932647
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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