Cleared Traditional

K251794 - Tenax® Laser Resistant Endotracheal Tube

K251794 is an FDA 510(k) clearance for Tenax Laser Resistant Endotracheal Tube, manufactured by Bryan Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 448-day FDA review.

K251794 · Bryan Medical, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Sep 2026
Decision
448d
Days
Class 2
Risk

K251794 is an FDA 510(k) clearance for the Tenax® Laser Resistant Endotracheal Tube. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Bryan Medical, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 3, 2026 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Bryan Medical, Inc. devices

FDA 510(k) Submission Details - K251794

510(k) Number K251794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2025
Decision Date September 03, 2026
Days to Decision 448 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
308d slower than avg
Panel avg: 140d · This submission: 448d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

AlvaMed, Inc.
Keira Jessop

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BTR Tube, Tracheal (w/wo Connector)

All 190
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