# K222292: F&P myAirvo 3

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare
- Decided: May 8, 2024 after 649 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K913368 (1992). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131895: Airvo 2 Humidifier, Myairvo 2 Humidifier, Fisher & Paykel Healthcare, Ltd. (2013) Summary page 5.

## Indications for use
The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 – 60 L/min depending on the patient interface. The myAirvo 3 is for patients in homes and long-term care facilities.

Source page: https://510kreport.com/device/K222292
Methodology: https://510kreport.com/methodology