ProSomnus RPMO2 OSA Device (RPMO2 OSA)

FDA 510(k) K252765 · Prosomnus Sleep Technologies

Substantially Equivalent

510(k) numberK252765

Submission

Device name
ProSomnus RPMO2 OSA Device (RPMO2 OSA)
Applicant
Prosomnus Sleep Technologies
Pleasanton, CA, US
Received
August 29, 2025
Decision date
April 6, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PLC – Sleep Appliances With Patient Monitoring
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5570
Specialty
Dental

For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.

Other 510(k)s with product code PLC

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K254304iNOS intraoral biosensorPLC · Traditional Achaemenid, LLC08/25/2026SE
K233497Rest Assure SystemPLC · Traditional Somnomed, Inc.10/03/2024SE
K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracPLC · Traditional Residential Home Sleep Services04/10/2020SE
K181571OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient MonitorPLC · Traditional Mark Abramson, D.D.S., Inc.04/19/2019SE
K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with…PLC · Traditional Prosomnous Sleep Technologies11/22/2017SE
K170606Acrylic Herbst Appliance with Micro-RecorderPLC · Traditional Gergen'S Orthodontic Lab11/16/2017SE
K161624MicrO2 OSA Device with Micro-RecorderPLC · Traditional Microdental, Inc.11/07/2016SE
K160239Tap 3, Tap 1PLC · Traditional Airway Management, Inc.08/10/2016SE
K150369SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac…PLC · Traditional Somnomed, Inc.06/18/2015SE

More from Somnomed, Inc.

510(k)DeviceDecision
K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device…LRK · Abbreviated 10/06/2022SE
K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient…LRK · Special 11/20/2020SE

Questions and answers

When was ProSomnus RPMO2 OSA Device (RPMO2 OSA) cleared by the FDA?

ProSomnus RPMO2 OSA Device (RPMO2 OSA) (K252765) received a 510(k) decision of Substantially Equivalent on April 6, 2026, 220 days after the submission was received.

What is the product code of K252765?

The FDA product code is PLC – Sleep Appliances With Patient Monitoring, a Class II (moderate risk) device regulated under 21 CFR 872.5570.