# K092846: Airvo Series Humidifiers

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Jan 27, 2010 after 134 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: 6 generations back to K913368 (1992). 18 ancestors in all.
30 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073706: Respiratory Humidifier, Model MR850, Fisher & Paykel Healthcare, Ltd. (2008) Summary page 1.
- K041900: HC604 Cpap Humidifier, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 1.

## Most influential descendants
- K121975: Airvo Humidifier Myairo Humidifier (2013), 25 descendants of its own
- K131895: Airvo 2 Humidifier, Myairvo 2 Humidifier (2013), 24 descendants of its own
- K162553: AirSpiral Heated Breathing Tube (2018), 15 descendants of its own
- K222197: F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range (2023), 3 descendants of its own
- K103316: Flowrest (2011), 3 descendants of its own

## Indications for use
The AIRVO and myAIRVO Humidifiers are to treat patients spontaneously breathing who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have upper airways bypassed. The AIRVO is for patients in hospitals. The myAIRVO is for home patients.

Source page: https://510kreport.com/device/K092846
Methodology: https://510kreport.com/methodology