Tenax® Laser Resistant Endotracheal Tube

FDA 510(k) K251794 · Bryan Medical, Inc.

Substantially Equivalent

510(k) numberK251794

Submission

Device name
Tenax® Laser Resistant Endotracheal Tube
Applicant
Bryan Medical, Inc.
Cincinnati, OH, US
Received
June 12, 2025
Decision date
September 3, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTR – Tube, Tracheal (W/Wo Connector)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5730
Specialty
Anesthesiology
Life-sustaining
Yes

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K253437Spiro-VISTABTR · Traditional Spiro Robotics06/12/2026SE
K250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal…BTR · Traditional Covidien, LLC10/06/2025SE
K243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™…BTR · Traditional Covidien, LLC09/25/2025SE
K243579AeroJet Ventilation CatheterBTR · Traditional Pipeline Medical Products, LLC08/13/2025SE
K251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer…BTR · Special William Cook Europe Aps06/11/2025SE
K250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu…BTR · Traditional Flexicare Medical Limited.05/20/2025SE
K242495LMA Fastrach ETT SUBTR · Traditional Teleflex Medical04/29/2025SE
K241451Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch…BTR · Traditional Teleflex Incorporated02/11/2025SE
K233341Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440…BTR · Traditional Covidien, LLC05/20/2024SE
K223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125…BTR · Traditional Covidien08/30/2023SE

More from Covidien

510(k)DeviceDecision
K213028Tenax Laser Resistant Endotracheal TubeBTR · Special 10/21/2021SE
K200761Tenax Laser Resistant Endotracheal TubeBTR · Traditional 11/25/2020SE
K150951aeris Balloon Dialation CatheterKTI · Traditional 06/25/2015SE

Questions and answers

When was Tenax® Laser Resistant Endotracheal Tube cleared by the FDA?

Tenax® Laser Resistant Endotracheal Tube (K251794) received a 510(k) decision of Substantially Equivalent on September 3, 2026, 448 days after the submission was received.

What is the product code of K251794?

The FDA product code is BTR – Tube, Tracheal (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5730.