# K170378: AirLife Adult Heated Wire BiPAP/NIV Circuit

- Pathway: 510(k) (Traditional)
- Applicant: Vyaire Medical
- Decided: Sep 14, 2017 after 219 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: 3 generations back to K913368 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983112: Respiratory Humidifier, Model # MR850, Fisher & Paykel Healthcare, Ltd. (1998) Summary page 4.

## Indications for use
AirLife Adult Heated Wire BiPAP/NIV Circuit is intended for use with adult population that requires mechanical ventilation. The AirLife Adult Heated Wire BiPAP/NIV Circuit is used with spontaneously breathing individuals that benefit from high flow therapy. The product is single use device, non-sterile and used in professional healthcare environments under a doctor’s supervision and by skilled clinicians. The AirLife Adult Heated Wire BiPAP/NIV Circuit is designed to work with noninvasive ventilators and compatible to the Fisher & Paykel MR850 humidifier.

Source page: https://510kreport.com/device/K170378
Methodology: https://510kreport.com/methodology