Airlife Heated Ventilator and Breathing Circuits

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

510(k) Number

K993833 ↗

FDA Product Code

BZE

Device Class

Class II

Regulation

21 CFR Part 868.5270

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Allegiance Healthcare Corp. →

• What is the Airlife Heated Ventilator and Breathing Circuits used for?

  It is designed for use with breathing system heaters to warm gases delivered to the patient airway during mechanical ventilation or anesthesia delivery, preventing heat loss in delivered gases for infant, pediatric, and adult patient populations in clinical settings.

• How is the Airlife Heated Ventilator and Breathing Circuits supplied and is it reusable?

  The device is supplied as a disposable, single-use product and is not intended for reuse; it is discarded after each patient use to ensure safety and prevent cross-contamination.

• What regulatory pathway was used for the Airlife Heated Ventilator and Breathing Circuits?

  It received FDA 510(k) clearance (K993833) on December 10, 1999, under regulation number 868.5270, with product code BZE, classified as a Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer).