ProSomnus RPMO2 OSA Device (RPMO2 OSA)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252765 FDA 510(k)
- FDA Product Code
- PLC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5570 FDA 510(k)
- Regulation Number
- 872.5570 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ProSomnus RPMO₂ OSA Device is a Sleep Appliance with Patient Monitoring, designed to treat obstructive sleep apnea (OSA). It combines nasal resistance modulation with continuous oxygen monitoring to promote airway stability and reduce apnea events during sleep. The device is classified as a Class II medical device under FDA regulations, adhering to standards for dental-related sleep therapy solutions.
This device is supplied as a reusable medical instrument, intended for use in clinical or home settings under professional supervision. It requires no sterilisation between uses but must be cleaned according to manufacturer guidelines. The device is MRI-unsafe and includes multiple registration numbers (e.g., 3008186372) for regulatory tracking. Authorised under FDA 510(k) clearance (K252765), it operates within the scope of dental advisory committee oversight for sleep-related submissions.
Frequently asked questions
What is the ProSomnus RPMO₂ OSA Device used for?
The ProSomnus RPMO₂ OSA Device is a Sleep Appliance with Patient Monitoring specifically designed to treat obstructive sleep apnea (OSA). It works by applying nasal resistance modulation to promote airway stability during sleep, while simultaneously monitoring continuous oxygen levels to help reduce apnea events. This dual-function approach supports better sleep quality and respiratory control for patients with OSA.
Is the ProSomnus RPMO₂ OSA Device reusable or single-use?
The ProSomnus RPMO₂ OSA Device is classified as a reusable medical instrument. While it does not require sterilization between uses, it must be cleaned thoroughly according to the manufacturer’s guidelines to maintain hygiene and functionality. This design allows for use in both clinical and home settings under professional supervision.
Can this device be used in an MRI environment?
No, the ProSomnus RPMO₂ OSA Device is not MRI-safe. Patients or caregivers should ensure the device is removed and stored safely away from MRI machines to avoid potential damage or interference with imaging procedures. Always follow manufacturer instructions for safe handling and storage.
What regulatory approvals does the ProSomnus RPMO₂ OSA Device hold?
The device holds FDA 510(k) clearance under the reference number K252765, classified as substantially equivalent to a predicate device. It falls under the oversight of the Dental Advisory Committee (DE) and is categorized as a Class II medical device, adhering to dental-related sleep therapy standards. Multiple registration numbers (e.g., 3008186372) are associated with the device for regulatory tracking.
How should the ProSomnus RPMO₂ OSA Device be stored?
The device should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality. Since it is reusable and not sterile, proper cleaning after each use is essential. Follow the manufacturer’s guidelines for maintenance to ensure longevity and safe operation. Additionally, avoid storing it near MRI machines due to its non-MRI-safe classification.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ProSomnus Sleep Technologies - Get Better Sleep, RPMO2 OSA Device - (Revamp) - ProSomnus Sleep Technologies, ProSomnus® Receives FDA Class II Clearance for RPMO2 OSA Device ..., PROSOMNUS RPMO2 USER MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252765 | Class II | Active |
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Manufacturer
- Manufacturer
- ProSomnus Sleep Technologies
Sources (1)
- FDA 510(k) K252765 24 fields · synced Oct 6, 2026