510(k) · Cleared
ClearedBoussignac/Vygon Endotracheal Tube, Model 6501.25/30/35 and 6502.70/75/80
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vygon SA · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Jun 10, 2004 as substantially equivalent to K802505 (National Catheter Co. Div. Mallinckrodt, 1981) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1981. 1 later device descends from it.
- Decided
- Jun 10, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K802505 (1981). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK802505 Double Lumen Tracheal TubeNational Catheter Co. Div. Mallinckrodt · 1981
- This deviceK040657 Boussignac/Vygon Endotracheal Tube, Model 6501.25/30/35 and…Vygon SA · 2004
- Descendant · cites it directly · 0 of its ownK211543 Wei Nasal Jet TubeWell Lead Medical Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K211543Wei Nasal Jet TubeWell Lead Medical Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802505 | Double Lumen Tracheal Tube | National Catheter Co. Div. Mallinckrodt | 1981 | — |
| 0 (this device) | K040657 | Boussignac/Vygon Endotracheal Tube, Model 6501.25/30/35 and 6502.70/75/80 | Vygon SA | 2004 | — |
| +1 | K211543 | Wei Nasal Jet Tube | Well Lead Medical Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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? (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 |
|---|---|---|---|
| * | K802505 | Double Lumen Tracheal TubeSummary page 1…Tracheal Tube The subject device is substantially equivalent to the Mallickrodt Hi-Lo®~Jet (K802505). and the Vygon's Double Lumen Tracheal Tube (K960795).… | 1981 |
| * | K960795 | Vygon Double Lumen Endotracheal TubeSummary page 1…acheal Tube The subject device is substantially equivalent to the Mallickrodt Hi-Lo®~Jet (K802505). and the Vygon's Double Lumen Tracheal Tube (K960795). Page - 47 - === Page… | 1996 |
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 |
|---|---|---|---|
| K211543 | Wei Nasal Jet Tube | 2022 | 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?
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 | — |
What is it indicated for?
The Boussignac/Vygon Endotracheal Tube is indicated for airway management. The insufflation canals permit the delivery of intermittent jet ventilation and the administration of oxygen during tracheobronchial suctioning procedures. They also provide a supplemental means for administering oxygen during bronchoscopies. In these ventilatory modes, the main lumen serves as a channel for the elimination of expired gases. When the insufflation port is capped…
Read the full statement (133 words)
The Boussignac/Vygon Endotracheal Tube is indicated for airway management. The insufflation canals permit the delivery of intermittent jet ventilation and the administration of oxygen during tracheobronchial suctioning procedures. They also provide a supplemental means for administering oxygen during bronchoscopies. In these ventilatory modes, the main lumen serves as a channel for the elimination of expired gases. When the insufflation port is capped, the Boussignac/Vygon Endotracheal Tube can function as a standard tracheal tube with ventilation occurring through the main lumen. The Boussignac/Vygon Endotracheal Tube is intended for oral/nasal intubation.
The monitoring/irrigation lumens may be used for monitoring airway pressure, for irrigation of a patient's tracheobronchial tree, to aid in the removal of accumulated secretions, for sampling tracheal gases, for anesthetizing the trachea, or for introducing suitable medication in accordance with standard medical practice.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040657 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040657: Boussignac/Vygon Endotracheal Tube, Model 6501.25/30/35 and 6502.70/75/80.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040657
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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