FDA.reportPublic FDA data

510(k) K252765

Device
ProSomnus RPMO2 OSA Device (RPMO2 OSA)
Applicant
Prosomnus Sleep Technologies
510(k) number
K252765
Product code
PLC
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-06
Date received
2025-08-29
Regulation
872.5570
Classification name
Sleep Appliances With Patient Monitoring
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Divya Mavalli
Address
5675 Gibraltar Dr. Pleasanton CA US 94588 94588

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PLC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233497Rest Assure SystemSomnomed, Inc.2024-10-03
K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services2020-04-10
K181571OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient MonitorMark Abramson, D.D.S., Inc.2019-04-19
K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorderProsomnous Sleep Technologies2017-11-22
K170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic Lab2017-11-16
K161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc.2016-11-07
K160239TAP 3, TAP 1Airway Management, Inc.2016-08-10
K150369SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorderSomnomed, Inc.2015-06-18