ProSomnus RPMO2 OSA Device (RPMO2 OSA)— 510(k) K252765
Substantially EquivalentProsomnus Sleep Technologies
FDA 510(k) clearance K252765 for ProSomnus RPMO2 OSA Device (RPMO2 OSA), Substantially Equivalent on 2026-04-06. Applicant: Prosomnus Sleep Technologies. Device class: 2.
Summary
Prosomnus Sleep Technologies' ProSomnus RPMO2 OSA Device (RPMO2 OSA) is filed under product code PLC (Sleep Appliances With Patient Monitoring). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 872.5570. Dental is both the classification panel and the review panel. It came in as a Traditional 510(k).
Prosomnus Sleep Technologies filed from Pleasanton, California. The record shows 220 calendar days from receipt to decision (August 29, 2025 to April 6, 2026).
Clearance details
- Applicant
- Prosomnus Sleep Technologies
- Product code
- Product code PLC
- Device class
- Class 2
- Regulation
- 21 CFR 872.5570
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
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More clearances from Prosomnus Sleep Technologies
view allData sourced from openFDA. This site is unofficial and independent of the FDA.