FDA.reportPublic FDA data

ProSomnus RPMO2 OSA Device

Primary DI
00850022853036
Brand
ProSomnus RPMO2 OSA Device
Company
PROSOMNUS SLEEP TECHNOLOGIES
Model
RPMO2 OSA
Device description
An intraoral OSA device with an embedded oximeter used for remote physiologic monitoring.
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter
LQZDevice, Jaw Repositioning
LRKDevice, Anti-Snoring
OUGMedical Device Data System
PLCSleep Appliances With Patient Monitoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
LQZDevice, Jaw RepositioningDental2
LRKDevice, Anti-SnoringDental2
OUGMedical Device Data SystemGeneral Hospital1
PLCSleep Appliances With Patient MonitoringDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252765000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252765000ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies2026-04-06PLC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022853036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022853036008500228530368500228530360850022853036

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning sleep-disordered breathing orthosisA removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.

Regulatory Flags#

DUNS number
075438768
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850022853050ProSomnus Charging StationCharging Station2026-04-24
00850022853067ProSomnus HWO2 DeviceHWO22026-04-24
00850022853012ProSomnus EVO [PH] Sleep and Snore DeviceEVO [PH]2024-03-29
00850022853029ProSomnus EVO [PH] Sleep and Snore Device with Patient MonitoringEVO [PH] with Patient Monitoring 2024-03-29
00863039000485ProSomnus EVO Sleep and Snore DeviceEVO2024-03-29
00863039000492ProSomnus EVO Sleep and Snore Device with Patient MonitoringEVO with Patient Monitoring 2024-03-29
00863039000409Prosomnus CA Sleep and Snore DeviceCA 2017-12-06
00863039000416Prosomnus IA MonogramIA Monogram2017-06-21
00863039000423Prosomnus IA MicrO2MicrO22017-06-21
00863039000430Prosomnus IA with Patient MonitoringIA Monogram Monitor2017-06-21
00863039000454Prosomnus CA Sleep and Snore Device with Patient MonitoringCA Monitor2017-12-06
00863039000447Prosomnus IA MicrO2 with Patient MonitoringMicrO2 with Monitoring2017-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012026111DaybreakSleepcare LLCLRK2026-10-19
10884521856271Touch SurgeryCovidien LPOUG2026-10-16
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
06946725572818APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572825APKAPK Technology Co.,Ltd.DQA2026-10-14
06945087500262MediWorksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.OUG2026-10-09
06945087500439EssilorSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.OUG2026-10-09
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
00850015699191Cloud Data Management PlatformCanary Medical USA LLCOUG2026-10-08
07290019919346OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919414OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919421OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919438OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
D745SN3D0Silent Nite 3D Sleep AppliancePrismatik Dentalcraft, IncLRK2026-10-07
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQA2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQA2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQA2026-10-04
06946725547168APKAPK Technology Co.,Ltd.DQA2026-09-24
06946725571705APKAPK Technology Co.,Ltd.DQA2026-09-20
06946725571903APKAPK Technology Co.,Ltd.DQA2026-09-20
07290016714265SleepSenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-09-08
06946725538005APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725548998APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONOUG2026-08-25