# K213088: ZQuiet Advance

- Pathway: 510(k) (Traditional)
- Applicant: Sleeping Well, LLC
- Decided: Jun 15, 2022 after 264 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: 1 generation back to K190058 (2019). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190058: PureSleep (OTC use), Sleep Science Partners, Inc. (2019) Summary page 4.

## Most influential descendants
- K253868: QuietLab Pro (2025), 0 descendants of its own

## Indications for use
ZQuiet Advance is intended as an aid in the reduction of snoring t0or aduLts at least 18 years old.

Source page: https://510kreport.com/device/K213088
Methodology: https://510kreport.com/methodology