# K093407: Zquiet Mouthpiece

- Pathway: 510(k) (Traditional)
- Applicant: Sleeping Well, LLC
- Decided: Jun 22, 2010 after 232 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: 5 generations back to K882303 (1989). 11 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090503: Zquiet Mouthpiece, Sleeping Well, LLC (2009) Summary page 1.

## Most influential descendants
- K180124: ZQuiet (2018), 6 descendants of its own
- 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

## Indications for use
The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults 18 years or older.

Source page: https://510kreport.com/device/K093407
Methodology: https://510kreport.com/methodology