Modified Fome-Cuf Silicone Tracheostomy Tube

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

510(k) Number

K885129 ↗

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 Modified Fome-Cuf Silicone Tracheostomy Tube used for?

  This device is designed for airway management in patients requiring long-term mechanical ventilation or tracheostomy. Its silicone construction and auto-expanding foam cuff conform to the tracheal wall, providing a secure seal while minimizing pressure on surrounding tissues. This reduces the risk of tracheal injury and enhances patient comfort during prolonged use.

• Is the Modified Fome-Cuf Silicone Tracheostomy Tube single-use or reusable?

  The Modified Fome-Cuf Silicone Tracheostomy Tube is intended for single-use in clinical settings like ICUs and operating rooms. This ensures sterility and reduces the risk of cross-contamination between patients.

• How is it supplied, and what does sterility mean for this device?

  The device is supplied sterile to ensure safe clinical use. Sterility means it has been processed to eliminate or reduce viable microorganisms to a level that meets regulatory standards, preventing infection risk in patients.

• What sizes and configurations are available for this tracheostomy tube?

  The Modified Fome-Cuf Silicone Tracheostomy Tube comes in multiple sizes and configurations, each identified by a unique FEI number (e.g., 3009771213, 3021632375). These variations accommodate different patient anatomies and clinical needs, ensuring proper fit and function.

• How should this device be stored to maintain its integrity?

  To preserve sterility and functionality, the device must be stored according to the manufacturer’s guidelines. This typically includes keeping it in its original packaging, away from direct sunlight, extreme temperatures, and moisture, until immediate clinical use.