Submission Details
| 510(k) Number | K122391 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 07, 2012 |
| Decision Date | January 10, 2013 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
MEDTRONIC XOMED, INC.
Jan 2013
Decision
156d
Days
Class 2
Risk
About This 510(k) Submission
K122391 is an FDA 510(k) clearance for the MEDTRONIC XOMED, INC., a Device, Anti-snoring (Class II — Special Controls, product code LRK), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on January 10, 2013, 156 days after receiving the submission on August 7, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.
Device Classification
| Product Code | LRK — Device, Anti-snoring |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.5570 |
Manufacturer
Similar Devices — LRK Device, Anti-snoring
All 208
K253845 · Ram.Shaw Pte. , Ltd.
· Mar 2026
K252531 · Myofunctional Research Co.
· Mar 2026
K252976 · Park Dental Research Corp.
· Dec 2025
K253868 · QuietLab, LLC
· Dec 2025
K252161 · Good Sleep CO Pte , Ltd.
· Nov 2025
K252525 · Aiomega, LLC
· Nov 2025
More from Medtronic Xomed, Inc.
View all
K251672
· ETN · Feb 2026
K230320
· ETN · Oct 2023
K231580
· ETN · Aug 2023
K213246
· ETN · Mar 2022
K210841
· PNZ · Aug 2021