V.I.P. Bird Infant - Pediatric Ventilator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K895541 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Bird 1000 Pv Portable Ventilator

  Class II

  FDA 510(k) K925422 Active Cleared 13 May 1993

• Bird Avea Ventilator

  Class II

  FDA 510(k) K022674 Active Cleared 6 Nov 2002

• 6400ST Interface MODULE-RS232

  Class II

  FDA 510(k) K880721 Active Cleared 14 Apr 1988

• Avea

  Class II

  FDA 510(k) K013642 Active Cleared 22 May 2002

• Bird Avian Port Military Vent Nsn 6530-01-374-8903

  Class II

  FDA 510(k) K933262 Active Cleared 29 Jul 1993

• Bird Microblender M.R.I.

  Class II

  FDA 510(k) K895695 Active Cleared 6 Jul 1990

See all devices from Bird Products Corp. →

• What is the V.I.P. Bird Infant - Pediatric Ventilator used for?

  The V.I.P. Bird Infant - Pediatric Ventilator is intended for the ventilation of neonatal, infant, and pediatric patients in a facility setting. It provides assist/control and SIMV/CPAP modes in both volume-cycled and time-cycled ventilation, making it suitable for continuous respiratory support in critically ill young patients requiring mechanical ventilation.

• Is the V.I.P. Bird Infant - Pediatric Ventilator reusable or single-use?

  The V.I.P. Bird Infant - Pediatric Ventilator is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning, disinfection, and maintenance between patients, in accordance with the manufacturer’s instructions for use and facility reprocessing protocols.

• What regulatory pathway was used for the V.I.P. Bird Infant - Pediatric Ventilator?

  The V.I.P. Bird Infant - Pediatric Ventilator received FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device. This traditional 510(k) submission was cleared under product code CBK and regulation number 868.5895, with decision date March 8, 1990.