Cleared Special

Tenax Laser Resistant Endotracheal Tube (K213028) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K213028 · Bryan Medical, Inc. · Anesthesiology device
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Oct 2021
Decision
30d
Days
Class 2
Risk

K213028 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 October 21, 2021 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bryan Medical, Inc. devices

Submission Details

510(k) Number K213028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2021
Decision Date October 21, 2021
Days to Decision 30 days
Submission Type Special
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
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.
Martha Kamrow Russell

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 39
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K213028.
Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
K233341 · Covidien, LLC · May 2024
Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
K223130 · Covidien · Aug 2023
Wei Nasal Jet Tube
K211543 · Well Lead Medical Co., Ltd. · Jul 2022
Tenax Laser Resistant Endotracheal Tube
K200761 · Bryan Medical, Inc. · Nov 2020
Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm
K192120 · Venner Medical (Singapore) Pte, Ltd. · Feb 2020
Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff
K190878 · Salter Labs, Inc. · Jan 2020