# K131895: Airvo 2 Humidifier, Myairvo 2 Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Oct 24, 2013 after 121 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913368 (1992). 20 ancestors in all.
24 later devices descend from it; 7 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121975: Airvo Humidifier Myairo Humidifier, Fisher & Paykel Healthcare, Ltd. (2013) Summary page 1.
- K073706: Respiratory Humidifier, Model MR850, Fisher & Paykel Healthcare, Ltd. (2008) Summary page 1.

## Most influential descendants
- 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
- K221338: F&P Airvo 3 (2023), 2 descendants of its own
- K212031: F&P 850 AirSpiral Adult NIV and NHF Circuit Kit (2022), 2 descendants of its own
- K211096: Optiflow Oxygen Kit (2022), 2 descendants of its own

## Recalls of this device
- Sep 18, 2025 · Class II · Z-0158-2026: When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may 
- Apr 2, 2024 · Class II · Z-1823-2024: Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible 

## Indications for use
The AIRVO 2 and myAIRVO 2 humidifiers are for the treatment of spontaneously breathing patients 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 AIRVO 2 is for patients in hospitals and long-term care facilities. The myAIRVO 2 is for patients in homes and long-term care facilities.

Source page: https://510kreport.com/device/K131895
Methodology: https://510kreport.com/methodology