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Percutaneous Dual Cannula Tracheostomy Tube With Low Pressure/Low Profile Cuff And Disposable Inner Cannula

by Mallinckrodt Medical

510(k) K963732

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK963732 Date26 Jun 1997ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1475-2010 FDA Unclassified (pre-2012) initiated 13 Apr 2010
    • Terminated Z-1474-2010 FDA Unclassified (pre-2012) initiated 13 Apr 2010

    Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.

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  • Withdrawn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
JOH
Device Class
Class II
Regulation
21 CFR Part 868.5800
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Percutaneous Dual Cannula Tracheostomy Tube is a medical device that provides an artificial airway for adult patients during percutaneous dilational tracheotomy. It consists of an outer cannula with cuff, inner cannula, neck plate, and inflation system. The device features a low pressure/low profile cuff and a disposable inner cannula.

This tracheostomy tube is supplied as a single-use device and is regulated under FDA 510K clearance with product code JOH. The device is available in various sizes and includes a flexible inner cannula that reduces torque during changes and protects against contamination. It is manufactured by Mallinckrodt Medical and received FDA clearance in 1997.

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Questions

AI-generated answers, 22 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 purpose of the Percutaneous Dual Cannula Tracheostomy Tube?

    This device provides an artificial airway for adult patients during percutaneous dilational tracheotomy procedures. It consists of an outer cannula with cuff, inner cannula, neck plate, and inflation system to maintain a secure airway.

  • Is this tracheostomy tube reusable or single-use?

    The Percutaneous Dual Cannula Tracheostomy Tube is supplied as a single-use device only. It should not be reused on different patients as this could compromise patient safety and device performance.

  • What sizes are available for this tracheostomy tube?

    The device is available in various sizes to accommodate different patient anatomies. The specific size options are not detailed in the provided information, but the manufacturer offers multiple configurations to meet clinical needs.

  • What regulatory status does this tracheostomy tube have?

    This device is regulated under FDA 510K clearance with product code JOH. It received FDA clearance in 1997 and is classified as substantially equivalent to predicate devices in the tracheostomy tube category.