LRKClass II
Device, Anti-Snoring
21 CFR 872.5570 / Dental
LRK is the FDA product code for Device, Anti-Snoring, a class II device type, regulated under 21 CFR 872.5570. As of , FDA records hold 215 510(k) clearances under this code, the most recent dated , and 10 recalls.
Classification record
- Product code
- LRK
- Device name
- Device, Anti-Snoring
- Regulation
- 21 CFR 872.5570
- Device class
- Class II
- Review panel
- Dental
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 215
- Ingested recalls
- 10
Clearances, product code LRK
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1993 | 2 |
| 1995 | 4 |
| 1996 | 3 |
| 1997 | 7 |
| 1998 | 5 |
| 1999 | 5 |
| 2001 | 2 |
| 2002 | 5 |
| 2003 | 3 |
| 2004 | 5 |
| 2005 | 3 |
| 2006 | 8 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 3 |
| 2010 | 8 |
| 2011 | 10 |
| 2012 | 10 |
| 2013 | 9 |
| 2014 | 11 |
| 2015 | 6 |
| 2016 | 10 |
| 2017 | 7 |
| 2018 | 10 |
| 2019 | 13 |
| 2020 | 5 |
| 2021 | 10 |
| 2022 | 11 |
| 2023 | 5 |
| 2024 | 6 |
| 2025 | 14 |
| 2026 | 8 |
Applicants with the most clearances
Product code LRK| Applicant | Clearances |
|---|---|
| Somnomed Inc. | 9 |
| Sleeping Well, LLC | 6 |
| Airway Management Inc. | 4 |
| Allen J. Moses, Dds, Ltd. | 4 |
| Always More Marketing Inc | 4 |
| Oventus Manufacturing Pty, Ltd. | 4 |
| Prismatik Dentalcraft, Inc. | 4 |
| Dental Imagineers, LLC | 3 |
| Fissiontech LLC | 3 |
| Good Sleep CO Pte, Ltd. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.