LRK — Device, Anti-Snoring Class II
FDA product code LRK covers "Device, Anti-Snoring", a Class II medical device regulated under 21 CFR 872.5570. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LRK
- Device Class
- Class II
- Regulation Number
- 872.5570
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261366 | somnomed | Virtus | June 12, 2026 |
| K261251 | endeavor commerce | Snorbliss® Anti-Snoring Device | June 11, 2026 |
| K261134 | koncept innovators | Dormiva Anti-Snoring Mouth Guard | May 14, 2026 |
| K252942 | shaeferh | ShaeferH | April 10, 2026 |
| K253845 | ram.shaw pte. | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | March 3, 2026 |
| K252531 | myofunctional research | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | March 2, 2026 |
| K252976 | park dental research | Park Dental Nylon MAD | December 18, 2025 |
| K253868 | quietlab | QuietLab Pro | December 5, 2025 |
| K252161 | good sleep co pte | Hushd Avera | November 25, 2025 |
| K252525 | aiomega | AIO Breathe | November 6, 2025 |
| K252698 | nightguard express | NightGuard Aire Max | November 3, 2025 |
| K253355 | fissiontech | Difiney Advanced Anti Snoring Device 4.0 | October 29, 2025 |
| K251784 | good sleep co pte | Hushd Pro Z-Link | October 24, 2025 |
| K251628 | dcstar | Mandibular Advancement Device L07 | October 22, 2025 |
| K250028 | dongguan yiyao science and technology development co | Anti Snore Mouthpiece | October 3, 2025 |
| K243752 | tmj clinic pc | Double Tube Herbst Appliance | September 17, 2025 |
| K252374 | airway technologies d/b/a airway management | Nylon flexTAP(R) | September 11, 2025 |
| K250353 | oniris | Oniris; Oniris Plus | September 4, 2025 |
| K250122 | splintek | SleepRight Snore Aid | May 19, 2025 |
| K250482 | fissiontech | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue | May 8, 2025 |