# K241216: myAir

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Corp
- Decided: Sep 26, 2024 after 148 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913396 (1992). 52 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200565: Galapogos, Resmed Corp (2021) Summary page 5.

## Most influential descendants
- K250624: myAir (2025), 1 descendant of its own
- K251657: Personalized Therapy Comfort Settings (PTCS) (2025), 0 descendants of its own

## Indications for use
The myAir app is indicated for patients: • prescribed with a compatible ResMed Air11 platform device to simulate therapy prior to using their device with their prescribed settings. It is an optional software accessory to allow patients to acclimate to 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 Air10 and Air11 PAP therapy devices and • new users who are prescribed a compatible NightOwl home sleep test (HST).

Source page: https://510kreport.com/device/K241216
Methodology: https://510kreport.com/methodology