Product code LRK: 510(k) clearances and predicates
Product code LRK covers Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT). FDA lists 215 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
215 clearances on file under product code LRK. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 11 |
| 2023 | 5 |
| 2024 | 6 |
| 2025 | 14 |
| 2026 so far | 8 |
Recent clearances
Newest LRK clearances in the FDA index, with applicant and decision date:
- K262104, Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT), applicant Ram.Shaw Pte., Ltd., decided 2026-08-27. FDA record
- K261912, SnØreNegatØr, applicant DnB Innovations, LLC, decided 2026-07-31. FDA record
- K261366, Virtus, applicant Somnomed, Inc., decided 2026-06-12. FDA record
- K261251, Snorbliss® Anti-Snoring Device, applicant Endeavor Commerce, LLC, decided 2026-06-11. FDA record
- K261134, Dormiva Anti-Snoring Mouth Guard, applicant Koncept Innovators, Inc., decided 2026-05-14. FDA record
- K252942, ShaeferH, applicant Shaeferh, LLC, decided 2026-04-10. FDA record
- K253845, Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB), applicant Ram.Shaw Pte. , Ltd., decided 2026-03-03. FDA record
- K252531, Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2), applicant Myofunctional Research Co., decided 2026-03-02. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include SnØreNegatØr, Virtus. Watch new LRK clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code LRK?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent LRK clearances include Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT).
How many 510(k) clearances use product code LRK?
215 at the time this page was generated, from openFDA records.
How do I find a predicate device under LRK?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new LRK clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.