# K233435: Peace N Quiet (0.7.0)

- Pathway: 510(k) (Traditional)
- Applicant: Pnq Health
- Decided: Feb 27, 2024 after 137 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: 7 generations back to K974501 (1998). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161562: Sound Options Tinnitus Treatment, Sound Options Tinnitus Treatments, Inc. (2016) Summary page 4.

## Indications for use
The Peace N Quiet device is indicated for use in the temporary relief of tinnitus symptoms. The device plays customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is for patients who are 18 years or older. This device should only be used with the advice of a physician, audiologist or other hearing healthcare professional.

Source page: https://510kreport.com/device/K233435
Methodology: https://510kreport.com/methodology