FDA product code LRK: Device, Anti-Snoring
LRK is the FDA product code for device, anti-snoring. It is a Class II device, regulated under 21 CFR 872.5570 and reviewed by the Dental panel. FDA has cleared 215 510(k) submissions under LRK, 44 in the last five years, from 156 different applicants. The average 510(k) review took 172 days (median 141); 140 days on average over the last three years. FDA has posted 10 recalls for LRK devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Anti-Snoring |
| Device class | Class II |
| Regulation | 21 CFR 872.5570 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LRK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 181 |
| 2018 | 10 | 199 |
| 2019 | 13 | 221 |
| 2020 | 5 | 95 |
| 2021 | 10 | 175 |
| 2022 | 11 | 174 |
| 2023 | 5 | 155 |
| 2024 | 6 | 204 |
| 2025 | 14 | 122 |
| 2026 | 8 | 95 |
Compare with all 510(k) review times · Search every LRK clearance
Top LRK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Somnomed, Inc. | 8 | 2026-06-12 |
| Sleeping Well, LLC | 6 | 2022-06-15 |
| Prismatik Dentalcraft, Inc. | 4 | 2023-11-14 |
| Oventus Manufacturing Pty, Ltd. | 4 | 2019-08-29 |
| Airway Management, Inc. | 4 | 2018-08-31 |
151 more applicants have LRK clearances. See the full list in Caduvo.
Most recent LRK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262104 | Ram.Shaw Pte., Ltd. | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) | 2026-08-27 | 65 |
| K261912 | DnB Innovations, LLC | SnØreNegatØr | 2026-07-31 | 53 |
| K261366 | Somnomed, Inc. | Virtus | 2026-06-12 | 46 |
| K261251 | Endeavor Commerce, LLC | Snorbliss® Anti-Snoring Device | 2026-06-11 | 56 |
| K261134 | Koncept Innovators, Inc. | Dormiva Anti-Snoring Mouth Guard | 2026-05-14 | 37 |
Recalls for LRK devices
10 product recalls in 5 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-04-27.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2022 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LRK?
LRK is the FDA product code for device, anti-snoring. It is a Class II device, regulated under 21 CFR 872.5570 and reviewed by the Dental panel.
What device class is LRK?
Class II, regulation 21 CFR 872.5570. Typical premarket route: 510(k).
How long does a 510(k) take for product code LRK?
Across 215 cleared submissions the average was 172 days from receipt to decision (median 141).
Which companies have the most LRK clearances?
Somnomed, Inc. (8); Sleeping Well, LLC (6); Prismatik Dentalcraft, Inc. (4); Oventus Manufacturing Pty, Ltd. (4); Airway Management, Inc. (4).
Have LRK devices been recalled?
Yes: 10 product recalls across 5 recall events; the most recent began 2026-04-27.
Next steps
- Run an FDA pathway report with predicate devices for product code LRK
- Run a recall and safety report across every LRK manufacturer
- Watch product code LRK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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