# K993833: Airlife Heated Ventilator and Breathing Circuits

- Pathway: 510(k) (Special)
- Applicant: Allegiance Healthcare Corp.
- Decided: Dec 10, 1999 after 28 days
- Product code: BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer)
- Device class: 2
- Regulation: 21 CFR 868.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Isothermal Heated Ventilator and Anesthesia Breathing Circuits: named in the summary without a submission number

## Indications for use
Breathing system heaters are defined as a device that is intended to warm breathing gases before they enter a patient’s airway.

Source page: https://510kreport.com/device/K993833
Methodology: https://510kreport.com/methodology