# K160531: Noiselezz

- Pathway: 510(k) (Abbreviated)
- Applicant: Firma Ingemarsson
- Decided: Sep 1, 2016 after 189 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.
No later device cites it as a predicate yet.
0 of 12 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 4.

## Indications for use
Noiselezz® is intended for the treatment of nighttime snoring in adults.

Source page: https://510kreport.com/device/K160531
Methodology: https://510kreport.com/methodology