# K180124: ZQuiet

- Pathway: 510(k) (Abbreviated)
- Applicant: Sleeping Well, LLC
- Decided: Jun 12, 2018 after 147 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 K882303 (1989). 12 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093407: Zquiet Mouthpiece, Sleeping Well, LLC (2010) Summary page 4.

## Most influential descendants
- K191618: SleepTight Mouthpiece STZ (2019), 3 descendants of its own
- K252531: Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (2026), 1 descendant of its own
- K201719: Vital Sleep (2021), 1 descendant of its own
- K261912: SnØreNegatØr (2026), 0 descendants of its own
- K253868: QuietLab Pro (2025), 0 descendants of its own

## Indications for use
ZQuiet is intended as an aid in the reduction of snoring for adults at least 18 years old.

Source page: https://510kreport.com/device/K180124
Methodology: https://510kreport.com/methodology