# K140435: Medley Gold

- Pathway: 510(k) (Traditional)
- Applicant: American Dental Sleep Medicine, Ip, LLC
- Decided: Jun 26, 2014 after 125 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)
- K971794: Elastic Mandibular Advancement (Ema) Appliance, Frantz Design, Inc. (1997) Summary page 1.
- K113201: Narval CC, Resmed Sas (2011) Summary page 1.
- K023836: The Suad Device, Strong Dental, Inc. (2003) Summary page 1.

## Indications for use
A customized mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.

Source page: https://510kreport.com/device/K140435
Methodology: https://510kreport.com/methodology