K251889
Substantially EquivalentmyAir
myAir is ResMed's patient-facing companion app for CPAP therapy — a software-only device cleared under product code MNS, which covers ventilator and respiratory therapy accessories. myAir pairs with ResMed's AirSense and AirCurve devices to provide therapy reporting, usage tracking, and behavioral-support features to patients.
Anesthesiology panel, Traditional 510(k). Patient-engagement apps for cleared durable medical equipment have become a routine 510(k) category, especially after FDA clarified that companion apps providing therapy-adjusting features need their own clearance. myAir has been through multiple version clearances over the years.
ResMed Corp files from San Diego, CA. Ten-month review clock, on the longer end for a software update — consistent with software-of-medical-device submissions generally.
- Applicant
- Resmed Corp
- Product code
- MNS
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Adverse 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.