All apps · Sleep & breathing

App icon of ProSomnus RPMO2, from the App Store

Is ProSomnus RPMO2 FDA approved or cleared?

Yes. ProSomnus RPMO2 by ProSomnus Sleep Technologies is named in the FDA register with a 510(k) clearance, latest decision in 2026.

In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.

At a glance

Product	ProSomnus RPMO2
Maker	ProSomnus Sleep Technologies
Care area	Sleep & breathing
What it does	Oral sleep apnea appliance with built-in oxygen and position monitoring
FDA	510(k), latest decision 2026
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	prosomnus.com
Status	FDA verified
Last checked	7 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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