Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)
FDA 510(k) K262104 · Ram.Shaw Pte., Ltd.
510(k) numberK262104
Submission
- Device name
- Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)
- Applicant
- Ram.Shaw Pte., Ltd.
Singapore, SG - Received
- June 23, 2026
- Decision date
- August 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LRK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261912 | SnØreNegatØrLRK · Traditional | DnB Innovations, LLC | 07/31/2026SE |
| K261366 | VirtusLRK · Special | Somnomed, Inc. | 06/12/2026SE |
| K261251 | Snorbliss® Anti-Snoring DeviceLRK · Traditional | Endeavor Commerce, LLC | 06/11/2026SE |
| K261134 | Dormiva Anti-Snoring Mouth GuardLRK · Special | Koncept Innovators, Inc. | 05/14/2026SE |
| K252942 | ShaeferHLRK · Traditional | Shaeferh, LLC | 04/10/2026SE |
| K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)LRK · Traditional | Ram.Shaw Pte. , Ltd. | 03/03/2026SE |
| K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)LRK · Traditional | Myofunctional Research Co. | 03/02/2026SE |
| K252976 | Park Dental Nylon MADLRK · Traditional | Park Dental Research Corp. | 12/18/2025SE |
| K253868 | QuietLab ProLRK · Traditional | QuietLab, LLC | 12/05/2025SE |
| K252161 | Hushd AveraLRK · Abbreviated | Good Sleep CO Pte , Ltd. | 11/25/2025SE |
More from Good Sleep CO Pte , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)LRK · Traditional | 03/03/2026SE |
Questions and answers
When was Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) cleared by the FDA?
Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) (K262104) received a 510(k) decision of Substantially Equivalent on August 27, 2026, 65 days after the submission was received.
What is the product code of K262104?
The FDA product code is LRK – Device, Anti-Snoring, a Class II (moderate risk) device regulated under 21 CFR 872.5570.