Prosomnus Sleep Technologies

FDA Regulatory Profile

Prosomnus Sleep Technologies appears in FDA public data with 0 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 6, 2026.

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)April 6, 2026
K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient MoOctober 6, 2022
K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient MonitoringNovember 20, 2020