Tenax® Laser Resistant Endotracheal Tube— 510(k) K251794
Substantially EquivalentBryan Medical, Inc.
FDA 510(k) clearance K251794 for Tenax® Laser Resistant Endotracheal Tube, Substantially Equivalent on 2026-09-03. Applicant: Bryan Medical, Inc.. Device class: 2.
Summary
Bryan Medical's Tenax Laser Resistant Endotracheal Tube is filed under BTR, tracheal tubes with or without connectors. The laser-resistant claim comes from the device name; the record gives no further detail.
Class II, 21 CFR 868.5730. Anesthesiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Bryan Medical filed from Cincinnati, Ohio. Review took 448 calendar days (June 12, 2025 to September 3, 2026).
Clearance details
- Applicant
- Bryan Medical, Inc.
- Product code
- Product code BTR
- Device class
- Class 2
- Regulation
- 21 CFR 868.5730
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code BTR
view all- K253437 — Spiro-VISTA
- K250173 — Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)
- K243785 — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced
- K243579 — AeroJet Ventilation Catheter
- K251499 — Frova Intubating Introducer (4 models)
More clearances from Bryan Medical, Inc.
view allAdverse events under product code BTR
product code BTR- Death
- 92
- Injury
- 1,263
- Malfunction
- 7,475
- Other
- 2
- Total
- 8,832
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.