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Tracheostomy Tube And Tube Cuff

FDA 510(k)

Class II (US FDA 510(k))

510(k) K924660

by Applied Medical Resources

Identifiers

510(k) Number
K924660 FDA 510(k)
FDA Product Code
JOH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5800 FDA 510(k)
Regulation Number
868.5800 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube.

Tracheostomy tubes are single patient use medical devices and usage should not exceed 30 days. Safe cuff pressure should be less than or equal to 25 cm H2O. The device is authorized under FDA 510K with K number K924660 and is classified as a Class II device under product code JOH.

Frequently asked questions

What is the purpose of this tracheostomy tube and tube cuff?

This device is intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff, when inflated, establishes a seal between the tracheal wall and the tracheostomy tube.

How long can this tracheostomy tube be used?

Tracheostomy tubes are single patient use medical devices and usage should not exceed 30 days. This ensures patient safety and prevents potential complications from prolonged use.

What is the safe cuff pressure for this device?

Safe cuff pressure should be less than or equal to 25 cm H2O. Maintaining proper cuff pressure is important to prevent tracheal damage while ensuring effective ventilation.

What is the regulatory status of this tracheostomy tube?

The device is authorized under FDA 510K with K number K924660 and is classified as a Class II device under product code JOH. This indicates it has been determined to be substantially equivalent to other legally marketed devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: eCFR :: 21 CFR 868.5800 -- Tracheostomy tube and tube cuff., PDF Tracheostomy cuff management, PDF Instructions for Use: Tracheostomy Tube - Cuffed & Uncuffed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Applied Medical Resources

Sources (1)

  • FDA 510(k) K924660 24 fields · synced Sep 28, 2026