myAir— 510(k) K251889
Substantially EquivalentResmed Corp
FDA 510(k) clearance K251889 for myAir, Substantially Equivalent on 2026-04-08. Applicant: Resmed Corp. Device class: 2.
Summary
myAir is ResMed's patient app for sleep apnea therapy. It reports nightly usage and mask data from the company's CPAP devices. It's filed under MNS, non-life-supporting continuous ventilators, which is where CPAP devices and their accessories sit.
Class II, 21 CFR 868.5895. The Anesthesiology panel reviewed it as a Traditional 510(k).
ResMed filed from San Diego, California. Review took 292 days (June 20, 2025 to April 8, 2026), long for software tied to devices that are already on the market. The record doesn't say what changed.
Clearance details
- Applicant
- Resmed Corp
- Product code
- Code MNS
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code MNS
view allMore clearances from Resmed Corp
view allAdverse events under product code MNS
product code MNS- Death
- 344
- Injury
- 1,160
- Malfunction
- 8,068
- Total
- 9,572
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.