# K220330: Soundly Anti Snoring Device

- Pathway: 510(k) (Abbreviated)
- Applicant: Greystone Ip, Ltd.
- Decided: Sep 8, 2022 after 216 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: 12 generations back to K882303 (1989). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191320: Slow Wave DS8, Slow Wave, Inc. (2020) Summary page 4.
- K190236: O2Vent Optima, Oventus Manufacturing Pty, Ltd. (2019) Summary page 4.

## Indications for use
The Soundly Mandibular Advancement Device is intended to reduce or alleviate snoring and mild to moderate Obstructive Sleep Apnea (OSA) whilst sleeping, in adults

Source page: https://510kreport.com/device/K220330
Methodology: https://510kreport.com/methodology