# K150014: Serenity

- Pathway: 510(k) (Traditional)
- Applicant: Sanuthera, Inc.
- Decided: Jul 27, 2015 after 203 days
- Product code: KLW (Masker, Tinnitus)
- Device class: 2
- Regulation: 21 CFR 874.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K974501 (1998). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130494: Unitron Tinnitus Masker Feature, Unitron Hearing (2013) Summary page 4.

## Indications for use
The Sanuthera’s Serenity device is indicated to provide a mean of sound enrichment therapy that is programmed by a hearing health care professional familiar with diagnosis and management of tinnitus as part of a personalized tinnitus management program to provide temporary relief from the tinnitus symptoms. The target population is primarily the adult population over 18 years of age.

Source page: https://510kreport.com/device/K150014
Methodology: https://510kreport.com/methodology