Total clearances
3
2020-11-20 → 2026-04-06
Name variants in FDA filings: Prosomnus Sleep Technologies / Prosomnus Sleep Technologies, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| LRK |
Device, Anti-Snoring |
Class II |
Dental |
2 |
2022-10-06 |
| PLC |
Sleep Appliances With Patient Monitoring |
Class II |
Dental |
1 |
2026-04-06 |
Filings
All 510(k) clearances (3)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-04-06 |
K252765 |
ProSomnus RPMO2 OSA Device (RPMO2 OSA) |
PLC |
Class II |
Dental |
| 2022-10-06 |
K221889 |
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring |
LRK |
Class II |
Dental |
| 2020-11-20 |
K202529 |
ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring |
LRK |
Class II |
Dental |