Prosomnus Sleep Technologies is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Prosomnus Sleep Technologies - FDA 510(k) Cleared Devices
Recent clearances: ProSomnus RPMO2 OSA Device (RPMO2 OSA), ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring
2
Total
2
Cleared
0
Denied
Prosomnus Sleep Technologies, develops intraoral medical devices for the treatment of obstructive sleep apnea and snoring. The company is based in Pleasanton, California, and serves hundreds of thousands of patients worldwide with non-CPAP therapy solutions.
The company has received 2 FDA 510(k) clearances from 2 total submissions. Dental devices represent 100% of the company's regulatory submissions. The first clearance was granted in 2022, with the latest clearance in 2026, demonstrating continued active development and market presence.
Prosomnus devices are engineered with precision intraoral technology and artificial intelligence-assisted design. The company's products are FDA-cleared, patented, and covered by commercial medical insurance, Medicare, TRICARE, and government-sponsored healthcare plans globally. Clinical data supports efficacy, safety, and high patient adherence rates compared to traditional sleep apnea therapies.
Explore the company's cleared device names, product codes, and clearance dates in the 510(k) database.
FDA 510(k) Regulatory Record - Prosomnus Sleep Technologies
2 devices