# K251889: myAir

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Corp
- Decided: Apr 8, 2026 after 292 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K971260 (1997). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132371: Easycare Online, Resmed, Ltd. (2013) Summary page 5.

## Indications for use
The myAir app is indicated for patients: » prescribed with a compatible ResMed Airl1 PAP or NIV device to simulate therapy prior to using their device with their prescribed settings. » prescribed with a compatible ResMed Airl1 PAP device to configure their settings to support therapy. It is an optional software accessory to allow patients to acclimate and operate their therapy device. » prescribed a NightOwl wearable device to provide the user interface to operate the connected device and aid in the home sleep testing process. The device is intended for home and hospital use for: * new and existing patients of ResMed Airl0 and Airl1 PAP and NIV therapy devices and * new users who are prescribed a compatible NightOwl home sleep apnea test (HSAT).

Source page: https://510kreport.com/device/K251889
Methodology: https://510kreport.com/methodology