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P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)

by Portex, Ltd.

510(k) K032112

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032112 Date26 Jan 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BTR
FDA applicant
Portex , Ltd.
Device Class
Class II
Regulation
21 CFR Part 868.5730
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a tracheal tube, tracheal (with or without connector), as defined by its classification name and medical specialty of Anesthesiology. It is a reinforced tracheal tube available in both cuffed and uncuffed configurations.

It is supplied as a medical device under FDA 510(k) authorization K032112, with product code BTR and regulation number 868.5730. The device was determined to be substantially equivalent through a traditional 510(k) review by the Anesthesiology advisory committee, with decision date January 26, 2004.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Portex reinforced tracheal tube used for?

    The Portex reinforced tracheal tube is designed for airway management in anesthesiology. It is available in both cuffed and uncuffed configurations to provide options for different clinical needs during intubation procedures.

  • How is the Portex reinforced tracheal tube supplied?

    The device is supplied as a medical device under FDA 510(k) authorization K032112. It is manufactured by Portex, Ltd. and distributed with appropriate product code BTR for regulatory identification purposes.

  • What is the regulatory status of the Portex reinforced tracheal tube?

    The device has FDA 510(k) authorization K032112 with product code BTR and regulation number 868.5730. It was determined to be substantially equivalent through a traditional 510(k) review by the Anesthesiology advisory committee, with decision date January 26, 2004.

  • Is the Portex reinforced tracheal tube available in different sizes?

    The device is available in both cuffed and uncuffed configurations, though specific size details are not provided in the available information. The reinforced design helps prevent kinking and ensures consistent airflow during use.