FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ProSomnus RPMO2 OSA Device (RPMO2 OSA)
K Number: K252765
·
Decision Apr 6, 2026
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
8
Applicant Total
2
Review Days
220
Basic Information
- Device Name
- ProSomnus RPMO2 OSA Device (RPMO2 OSA)
- K Number
- K252765
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Prosomnus Sleep Technologies
- Date Received
- August 29, 2025
- Decision Date
- April 6, 2026
- Product Code
- PLC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| PLC | Sleep Appliances With Patient Monitoring | FDA class 2 | Dental |
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Other Clearances by Prosomnus Sleep Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K221889 | ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring | Oct 6, 2022 | Substantially Equivalent |