# K151959: AirLife Infant Single Limb Heated Wire Circuit

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion, Inc.
- Decided: Jan 20, 2016 after 188 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 heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient’s airway. The heated breathing circuit is used with Fisher and Paykel heated humidifier MR850. The AirLife Infant Single Limb Heated Wire Circuit is intended for use with pediatric population, specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 years of age) pediatric subgroups. 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.

Source page: https://510kreport.com/device/K151959
Methodology: https://510kreport.com/methodology