Bivona Aire-Cuf(R) Pediatric Tracheostomy Tube

• • Terminated Z-2946-2020 FDA Class II ·initiated 28 Aug 2020

  Label has the incorrect size for the tracheotomy tube.

• • Terminated Z-0930-05 FDA Unclassified (pre-2012) ·initiated 26 Apr 2005

  The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.

• • Terminated Z-0302-06 FDA Unclassified (pre-2012) ·initiated 17 Feb 2005 ·on shared 510(k) K914088

  The word PED was printed on the neckflange instead of the word NEO.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K914088 ↗

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 →