Class Class II
SleepRight Snore Aid (K250122)
Description
SleepRight Snore Aid by Splintek, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250122
Clearance Date2025-05-19
Clearance TypeTraditional
Product CodeLRK
Regulation Number872.5570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250122
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. SleepRight Snore Aid (K250122) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223901 | ApneaRX Pro | Apnea Sciences Coporation | 2023 |
| K200657 | SmartGuard Anti-Snoring Device | Smartguard Rx, Inc. | 2021 |
| K172223 | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2017 |
| K170825 | SnoreRx | Apnea Sciences Corporation | 2017 |
Trace the full predicate network for K250122
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.