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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K251794
Device Name Tenax® Laser Resistant Endotracheal Tube
Applicant
Bryan Medical, Inc.
6100 Wooster Pike
Cincinnati,  OH  45227
Applicant Contact David Rattigan
Correspondent
AlvaMed, Inc.
935 Great Plain Ave., Suite 166
Needham,  MA  02492
Correspondent Contact Keira Jessop
Regulation Number868.5730
Classification Product Code
BTR  
Subsequent Product Code
BSK  
Date Received06/12/2025
Decision Date 09/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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