# K253868: QuietLab Pro

- Pathway: 510(k) (Traditional)
- Applicant: QuietLab, LLC
- Decided: Dec 5, 2025 after 2 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: 8 generations back to K882303 (1989). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180124: ZQuiet, Sleeping Well, LLC (2018) Summary page 5.
- K213088: ZQuiet Advance, Sleeping Well, LLC (2022) Summary page 5.
- K201719: Vital Sleep, The Snore Reliever Company, LLC (2021) Summary page 5.
- K121761: Somnoguard SP Soft, Tomed Dr. Toussaint GmbH (2012) Summary page 5.

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

Source page: https://510kreport.com/device/K253868
Methodology: https://510kreport.com/methodology