Modified Aire-Cuf Silicone Tracheostomy Tube

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

510(k) Number

K885130 ↗

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 Aire-Cuf Silicone Tracheostomy Tube used for?

  The device is intended for use in clinical settings requiring tracheostomy access, providing patient comfort with its all-silicone construction.

• Is the Modified Aire-Cuf Tracheostomy Tube supplied sterile?

  Yes, the device is supplied as a sterile, single-use tracheostomy tube to ensure patient safety and prevent infection.

• What is the regulatory classification of the Modified Aire-Cuf Tracheostomy Tube?

  The device is regulated under FDA device class 2 with regulation number 868.5800, and has been cleared via the traditional 510(k) pathway with K number K885130.

• Who manufactures the Modified Aire-Cuf Tracheostomy Tube?

  The device is manufactured by Bivona Medical Technologies.