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 from ResMed is filed under MNS, non-life-supporting continuous ventilators. The record doesn't describe what myAir is or does.
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).
Clearance details
- Applicant
- Resmed Corp
- Product code
- Product 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.