FDA cleared the Tenax® Laser Resistant Endotracheal Tube from Bryan Medical, Inc. on Sep 3, 2026 under K251794, a traditional 510(k). The device falls under product code BTR, Tube, Tracheal (W/Wo Connector), regulated at 21 CFR 868.5730 as a Class 2 device. The review panel was Anesthesiology.
FDA logged the submission as received on Jun 12, 2025. The decision came 448 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for Bryan Medical, Inc. in the last 12 months of the tracker.