510(k) · Cleared
ClearedTenax® Laser Resistant Endotracheal Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bryan Medical, Inc. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Sep 3, 2026 as substantially equivalent to K213028 (Bryan Medical, Inc., 2021) after a 448-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Sep 3, 2026
- Review
- 448 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K993582 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK993582 Modification to Laser-Shield IIXomed, Inc. · 2000
- 2 generations backK200761 Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2020
- 1 generation backK213028 Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2021
- This deviceK251794 Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993582 | Modification to Laser-Shield II | Xomed, Inc. | 2000 | — |
| −2 | K200761 | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2020 | — |
| −1 | K213028 | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2021 | — |
| 0 (this device) | K251794 | Tenax® Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2026 | — |
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 K250173 Shiley™ Oral RAE Tracheal Tube Cuffless…score 11.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K213028 | Tenax Laser Resistant Endotracheal TubeSummary page 5…Product Code: BTR, BSK Review Panel: Anesthesiology Primary Predicate Clearance: K213028 Device: Trade/Device Name: Tenax® Laser Resistant Endotracheal Tube Manufac… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
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. 2026, this device’s year, is highlighted.
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 Tenax® Laser Resistant Endotracheal Tube is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10.60 microns), KTP (532 nm) or Blue (445nm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthetic gases or to overcome emergency obstruction of an airway. The device is intended for use in adult patients.
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/K251794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251794: Tenax® Laser Resistant Endotracheal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251794
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026