# K182202: Sleepapp

- Pathway: 510(k) (Abbreviated)
- Applicant: Comfort Acrylics, Inc.
- Decided: Jan 11, 2019 after 150 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SLEEPAPPADV™ is intended for the management of snoring and mild to moderate obstructive sleep apnea in adults 18 years of age and older.

Source page: https://510kreport.com/device/K182202
Methodology: https://510kreport.com/methodology