ProSomnus RPMO2 OSA Device (RPMO2 OSA)— 510(k) K252765

Name: FDA 510(k) clearance K252765
Creator: U.S. Food and Drug Administration
Published: 2026-04-06

Substantially Equivalent

Prosomnus 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.

Clearance details

Applicant: Prosomnus Sleep Technologies
Product code: Code PLC
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2025-08-29
Decision date: 2026-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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