Is ProSomnus FDA approved? FDA 510(k) Clearances Checked

Short answer: ProSomnus has 3 FDA 510(k) clearances on record, not an FDA approval. The most recent is K252765 ("ProSomnus RPMO2 OSA Device (RPMO2 OSA)"), decided April 6, 2026 for Prosomnus Sleep Technologies (Pleasanton, CA). The earliest in this list is K202529, decided November 20, 2020.

Product codes: PLC (Sleep Appliances With Patient Monitoring, Class II, 21 CFR 872.5570), LRK (Device, Anti-Snoring, Class II, 21 CFR 872.5570)
Applicants as filed: Prosomnus Sleep Technologies; Prosomnus Sleep Technologies, Inc.
FDA decision on every record listed: Substantially Equivalent (cleared)

ProSomnus 510(k) records

FDA 510(k) records for ProSomnus
510(k) number	Device name (as filed)	Applicant	Decision date	Product code	Decision
K252765	ProSomnus RPMO2 OSA Device (RPMO2 OSA)	Prosomnus Sleep TechnologiesPleasanton, CA	April 6, 2026	PLC	Substantially Equivalent
K221889	ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring	Prosomnus Sleep TechnologiesPleasanton, CA	October 6, 2022	LRK	Substantially Equivalent
K202529	ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring	Prosomnus Sleep Technologies, Inc.Pleasanton, CA	November 20, 2020	LRK	Substantially Equivalent

Each 510(k) number links to FDA's own record, where you can read the summary or statement and the intended use. We grouped these records under ProSomnus by device and applicant name; if a product you are looking at is sold under a different name, search the lookup or FDA's database directly.

Is ProSomnus "FDA approved"?

Not in FDA's sense of the word. Anti-snoring and jaw-repositioning mouthpieces are Class II devices that reach the market through a 510(k) premarket notification. FDA "clears" a 510(k) when it finds the device substantially equivalent to one already legally sold. "Approval" is a different process (premarket approval, or PMA) used mainly for higher-risk Class III devices. So the accurate phrase for ProSomnus is "FDA cleared", for the specific models and dates in the table above.

What this page is, and what it is not

This is a copy of public FDA records, not a review. 40 Winks has not tested these devices for this page.
A 510(k) clearance means FDA found a device substantially equivalent to a device already legally on the market. It is not an FDA approval, it is not an endorsement by FDA or by 40 Winks, and it does not show that a device will work for you. FDA's own rule (21 CFR 807.97) says a 510(k) clearance does not mean FDA has approved the device.
A clearance covers the specific device and model in the filing. Check that the product you are buying matches the 510(k) number and name, and read the intended use in FDA's record.
Loud, regular snoring can be a sign of obstructive sleep apnea. Talk to a doctor or a dentist trained in sleep medicine before relying on a mouthpiece, and ask whether a sleep test makes sense.

How to check a clearance yourself

Open FDA's 510(k) Premarket Notification database.
Search by the 510(k) number (it starts with K) or by the device or company name.
Open the record and read the device name, applicant, decision date and the linked summary or statement, which describes the intended use.
If a seller says "FDA approved" or "FDA cleared" but gives no 510(k) number, ask for it.

Other sleep devices in this lookup

Search all 254 sleep-appliance records in the FDA clearance lookup, or browse by product code: Anti-Snoring Devices (LRK), Jaw Repositioning Devices (LQZ), Sleep Appliances With Patient Monitoring (PLC).