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Rae II Tracheal Tube

by Mallinckrodt Medical

510(k) K941246

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 NumberK941246 Date11 Apr 1994ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 868.5730
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Rae II Tracheal Tube is a tracheal tube with or without a connector designed for airway management. It is classified as a class 2 medical device used in the field of anesthesiology.

This device is authorized under FDA 510(k) number K941246. It is supplied by Mallinckrodt Medical and is regulated under 21 CFR 868.5730.

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Questions

AI-generated answers, 27 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 primary purpose of the Rae II Tracheal Tube?

    The Rae II Tracheal Tube is designed for airway management. It is specifically classified for use within the field of anesthesiology to assist in maintaining a patient's airway.

  • How is the Rae II Tracheal Tube regulated?

    This device is regulated under 21 CFR 868.5730 and is authorized for use under FDA 510(k) number K941246.

  • Does the Rae II Tracheal Tube come with a connector?

    The Rae II Tracheal Tube is available in configurations both with and without a connector to accommodate different clinical requirements for airway management.