Modified Aire-Cuf Silicone Tracheostomy Tube

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

510(k) Number

K896548 ↗

FDA Product Code

JOH

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Fome-Cuf-Wire Re-Enforced, Aire-Cuf Wire

  Class II

  FDA 510(k) K792035 Active Cleared 26 Oct 1979

• Aire-Cuf Polyester Re-Enforced Endotracheal Tube

  Class II

  FDA 510(k) K872366 Active Cleared 17 Aug 1987

• Fome-Cuf Pvc

  Class II

  FDA 510(k) K780583 Active Cleared 12 May 1978

• Fome-Cuf and Aire Cuf Tracheostomy Tubes

  Class II

  FDA 510(k) K862267 Active Cleared 18 Jun 1986

• Bivona Nasal Turbinate Stent

  Class I

  FDA 510(k) K935053 Active Cleared 1 Jul 1994

• Bivona Carden Intermittent Jetting Device

  Class II

  FDA 510(k) K895946 Active Cleared 9 Jan 1990

See all devices from Bivona Medical Technologies →

• What is the primary purpose of the Modified Aire-Cuf Silicone Tracheostomy Tube in clinical settings?

  The Modified Aire-Cuf Silicone Tracheostomy Tube is designed for airway management in patients who require tracheostomy. Its inflatable cuff helps maintain a patent airway, reduces the risk of aspiration, and ensures secure ventilation support, making it ideal for use in intensive care units and other clinical settings where prolonged airway support is necessary.

• Is this tracheostomy tube reusable, or is it intended for single-use only?

  This device is explicitly supplied as a single-use, sterile product, meaning it is intended for one-time use in a clinical setting. Reuse is not recommended or supported by the manufacturer.

• What materials is the Modified Aire-Cuf Silicone Tracheostomy Tube made from, and why does that matter?

  The tube is constructed entirely of silicone, including the shaft and neck flange, which enhances patient comfort by reducing irritation and improving tolerance during prolonged use. Silicone is also known for its durability and biocompatibility, making it suitable for sensitive airway applications.

• How do I determine the correct size for a patient, and what size options are available?

  The tube comes in multiple sizes, each identified by a unique FEI number (e.g., 3009771213, 3021632375, etc.). The correct size should be selected based on the patient’s tracheal anatomy and clinical needs, typically guided by a healthcare provider. The manufacturer provides a range of sizes to accommodate different patient requirements.

• Does this tracheostomy tube include any additional features to simplify tube changes or insertion?

  Yes, the Modified Aire-Cuf Silicone Tracheostomy Tube includes a clip-in obturator with a hollow tip, which facilitates easier and safer tube changes by providing support during insertion and removal.