# K153234: AirLife Adult Heated Wire Circuit

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion, Inc.
- Decided: Jul 7, 2016 after 241 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
Longest line of descent: 1 generation back to K000697 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000697: Modification to Airlife Heated Ventilator and Anesthesia Breathing Circuits, Allegiance Healthcare Corp. (2000) Summary page 4.

## Indications for use
The AirLife Adult Heated Wire Circuit is intended to warm breathing gases before they enter a patient’s airway. The AirLife Adult Heated Wire Circuit is used with the adult patient population that requires mechanical ventilation, positive pressure breathing or general medical gases. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a doctor’s supervision and by skilled clinicians. The AirLife Adult Heated Wire Circuit is compatible to the Fisher & Paykel MR850 humidifier.

Source page: https://510kreport.com/device/K153234
Methodology: https://510kreport.com/methodology