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 Oct 21, 2021 as substantially equivalent to K200761 (Bryan Medical, Inc., 2020) after a 30-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Oct 21, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K993582 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK993582 Modification to Laser-Shield IIXomed, Inc. · 2000
- 1 generation backK200761 Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2020
- This deviceK213028 Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK251794 Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993582 | Modification to Laser-Shield II | Xomed, Inc. | 2000 | — |
| −1 | K200761 | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2020 | — |
| 0 (this device) | K213028 | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2021 | — |
| +1 | K251794 | Tenax® Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 12.5 · 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? (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 |
|---|---|---|---|
| * | K200761 | Tenax Laser Resistant Endotracheal TubeSummary page 4…if ication Name: Tracheal tube (21 CFR 868.5730) Regulatory Class: II Product Code: BTR, BSK 1.3. Predicate Device Tenax® Laser Resistant Endotracheal Tube, K200761 1.4. Device Description The Tenax® Laser Resistant Endotracheal Tube is an endotracheal tube with two inflatable cuffs. It is… | 2020 |
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 |
|---|---|---|---|
| K251794 | Tenax® Laser Resistant Endotracheal Tube | 2026 | 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?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 20.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K251794 (Bryan Medical, Inc., 2026) has gone furthest, with 0 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. 2021, 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 Laser (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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213028: 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/K213028
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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