# K250122: SleepRight Snore Aid

- Pathway: 510(k) (Traditional)
- Applicant: Splintek, Inc.
- Decided: May 19, 2025 after 122 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K071404 (2007). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170825: SnoreRx, Apnea Sciences Corporation (2017) Summary page 5.
- K223901: ApneaRX Pro, Apnea Sciences Coporation (2023) Summary page 5.

## Indications for use
Prescription (Rx): The SleepRight Snore Aid is intended for use on adults 18 years of age or older as an aid for the reduction in mild to moderate obstructive sleep apnea (OSA) and/or snoring. OTC: The SleepRight Snore Aid is intended for use on adults 18 years of age or older as an aid for the reduction of snoring.

Source page: https://510kreport.com/device/K250122
Methodology: https://510kreport.com/methodology