FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
myAir
K Number: K251889
·
Decision Apr 8, 2026
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
46
Applicant Total
17
Review Days
292
Basic Information
- Device Name
- myAir
- K Number
- K251889
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Resmed Corp
- Date Received
- June 20, 2025
- Decision Date
- April 8, 2026
- Product Code
- MNS
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNS | Ventilator, Continuous, Non-Life-Supporting | FDA class 2 | Anesthesiology |
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Other Clearances by Resmed Corp
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|---|---|---|---|
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| K251657 | Personalized Therapy Comfort Settings (PTCS) | Dec 5, 2025 | Substantially Equivalent |
| K250624 | myAir | May 28, 2025 | Substantially Equivalent |
| K241939 | EasyCare Tx 2 | Sep 27, 2024 | Substantially Equivalent |
| K241216 | myAir | Sep 26, 2024 | Substantially Equivalent |
| K200565 | Galapogos | Jan 17, 2021 | Substantially Equivalent |
| K140124 | S9 ELOUERA | May 12, 2014 | Substantially Equivalent |
| K113801 | VPAP ADAPT | May 25, 2012 | Substantially Equivalent |
| K111148 | S8 ASPEN WITH H4I PLUS | Jun 30, 2011 | Substantially Equivalent |