# K151303: AirLife Infant Heated Wire Circuit

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Jan 21, 2016 after 248 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: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913368 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020332: Respiratory Humidifier, Model MR850, Fisher & Paykel Healthcare, Ltd. (2003) Summary page 4.
- K000697: Modification to Airlife Heated Ventilator and Anesthesia Breathing Circuits, Allegiance Healthcare Corp. (2000) Summary page 4.

## Recalls of this device
- Apr 10, 2025 · Class I · Z-1698-2025: Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ 
- Apr 10, 2025 · Class I · Z-1697-2025: Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ 

## 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 MR850 humidifier. The AirLife Infant Heated Wire Circuit is used 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. The AirLife Infant Heated Wire Circuit is used for flow rates greater than 4 LPM.

Source page: https://510kreport.com/device/K151303
Methodology: https://510kreport.com/methodology