# K221338: F&P Airvo 3

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare
- Decided: Jan 27, 2023 after 263 days
- Product code: QAV (High Flow/High Velocity Humidified Oxygen Delivery Device)
- Device class: 2
- Regulation: 21 CFR 868.5454
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K913368 (1992). 22 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170001: Precision Flow® HVNI, Vapotherm, Inc. (2018) Summary page 4.
- K131895: Airvo 2 Humidifier, Myairvo 2 Humidifier, Fisher & Paykel Healthcare, Ltd. (2013) Summary page 4.

## Most influential descendants
- K233643: F&P Airvo 3 NIV (PT311US) (2024), 1 descendant of its own
- K242931: HFT750U (2025), 0 descendants of its own

## Recalls of this device
- Aug 7, 2024 · Class II · Z-3262-2024: Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my expe

## Indications for use
The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities. It adds heat and moisture to the flow of air, or blended air/medical oxygen mixture, and assures the user of the air/oxygen mixture using an integrated oxygen analyzer and visual display. The flow may be from 2 to 70 L/min depending on the patient interface. The Airvo 3 provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals and sub-acute facilities. The Airvo 3 provides high flow gases with simultaneous oxygen delivery through nasal cannula interfaces to augment the breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. The Airvo 3 is not intended to provide total ventilatory requirements and is not for use during field transport.

Source page: https://510kreport.com/device/K221338
Methodology: https://510kreport.com/methodology