FDA clearance lookup
Is your anti-snoring mouthpiece FDA cleared?
Sellers often say “FDA approved.” Here is what FDA's public 510(k) records actually show, brand by brand, with the K-number so you can check it yourself.
Source: FDA 510(k) premarket notification database via openFDA. Retrieved (FDA data last updated November 2, 2026).
Search all 254 records by device, company or 510(k) number, or pick a brand below. Every number on these pages comes from FDA's 510(k) database (via openFDA), retrieved November 13, 2026.
Cleared vs. approved: the short version
Anti-snoring mouthpieces and jaw-repositioning appliances are Class II medical devices (21 CFR 872.5570). They reach the U.S. market through a 510(k) premarket notification: the maker shows FDA that the device is substantially equivalent to one already legally sold, and FDA "clears" it. "FDA approved" refers to a different, stricter process (premarket approval) that these devices generally don't go through, and FDA's rules say a 510(k) clearance should not be presented as an approval.
Brands and their FDA 510(k) records
| Brand | 510(k)s on record | Most recent | Decision date |
|---|---|---|---|
| ApneaRx | 2 | K223901 | September 1, 2023 |
| AVEOtsd | 1 | K231663 | September 18, 2023 |
| Difiney | 3 | K253355 | October 29, 2025 |
| Elevo | 2 | K213475 | January 27, 2022 |
| EMA appliance | 3 | K232735 | May 3, 2024 |
| Good Morning Snore Solution | 2 | K193239 | January 3, 2020 |
| Hushd | 3 | K252161 | November 25, 2025 |
| Myosa | 1 | K252531 | March 2, 2026 |
| Oventus O2Vent | 4 | K190236 | August 29, 2019 |
| ProSomnus | 3 | K252765 | April 6, 2026 |
| PureSleep | 2 | K190058 | April 11, 2019 |
| ResMed Narval CC | 1 | K113201 | December 1, 2011 |
| Silent Nite | 4 | K233434 | November 14, 2023 |
| SilentZPro | 1 | K220688 | December 2, 2022 |
| SleepRight Snore Aid | 1 | K250122 | May 19, 2025 |
| SleepTight Mouthpiece | 2 | K191618 | December 11, 2019 |
| SmartGuard anti-snoring device | 1 | K200657 | August 23, 2021 |
| Snorbliss | 1 | K261251 | June 11, 2026 |
| Snore Bandit | 1 | K210910 | July 1, 2021 |
| Snore Guard | 2 | K103004 | February 25, 2011 |
| SnoreRx | 3 | K170825 | August 18, 2017 |
| SomnoMed (SomnoDent) | 11 | K261366 | June 12, 2026 |
| Somnos and Dormiva mouth guards | 2 | K261134 | May 14, 2026 |
| Soundly | 1 | K220330 | September 8, 2022 |
| TAP (Airway Management) | 7 | K252374 | September 11, 2025 |
| VitalSleep | 2 | K201719 | January 14, 2021 |
| Vivos appliances (DNA, mRNA, mmRNA) | 4 | K234089 | September 16, 2024 |
| ZQuiet | 6 | K213088 | June 15, 2022 |
| Zyppah | 1 | K182312 | January 24, 2019 |
| SnoreMeds | No record found in FDA's databases (searched November 13, 2026) | ||
| AirSnore | No record found in FDA's databases (searched November 13, 2026) | ||
Browse by FDA product code
- LRK: Device, Anti-Snoring (217 clearances)
- LQZ: Device, Jaw Repositioning (27 clearances)
- PLC: Sleep Appliances With Patient Monitoring (10 clearances)
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.