Shiley Low Pressure Thin-Cuffed Trach.

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K792222 ↗

FDA Product Code

EQN

Device Class

Class II

Regulation

21 CFR Part 874.4760

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Stockert-Shiley Caps Venous Occlusion Clamp

  Class I

  FDA 510(k) K864890 Active Cleared 19 Feb 1987

• Basic Heater-Cooler Unit, 115/100V 16-02-20

  Class II

  FDA 510(k) K883330 Active Cleared 26 Sep 1988

• Schneider-Shiley Y-Connector with Rotator

  Class II

  FDA 510(k) K862464 Active Cleared 28 Aug 1986

• Expanded Use for Shiley 3l Cardiotomy Reservoir

  Class II

  FDA 510(k) K872721 Active Cleared 23 Sep 1987

• Shiley Venous Reservoir

  Class II

  FDA 510(k) K854841 Active Cleared 10 Feb 1986

• Arterial Embolectomy Catheter

  Class II

  FDA 510(k) K840198 Active Cleared 3 Aug 1984

See all devices from Shiley, Inc. →

• What is the primary function of the Shiley Low Pressure Thin-Cuffed Tracheostomy Tube?

  This device is designed to provide long-term ventilation for patients. It functions by bypassing upper airway obstructions and assisting clinicians in the management of tracheal and bronchial secretions.

• What configurations are available for this tracheostomy tube?

  The device is available in both cuffed and cuffless configurations. Additionally, it offers options for either disposable or reusable inner cannulas to suit different clinical requirements.

• Does the tube have any special material properties for patient comfort?

  Yes, the tube features a specialized design that softens when it reaches body temperature, which helps improve patient comfort during long-term use.

• How does the device connect to ventilation equipment?

  The tube includes an integrated 15-mm connector, which is a standard size designed to facilitate easy and secure attachment to ventilation circuits.

• What is the regulatory status of this device?

  The Shiley Low Pressure Thin-Cuffed Tracheostomy Tube is regulated under FDA 510K clearance, having been determined to be substantially equivalent to other devices in its class.