Clearance Summary
ProSomnus RPMO2 OSA Device (RPMO2 OSA) received FDA 510(k) clearance under submission number K252765, sponsored by Prosomnus Sleep Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2026-04-06.
- Submission: K252765
- Applicant / Sponsor: Prosomnus Sleep Technologies
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2026-04-06
Classification & Regulation
This clearance is catalogued under FDA product code PLC and 21 CFR 872.5570, within the Dental review panel as a Class II device.