# K242214: Sonu

- Pathway: 510(k) (Traditional)
- Applicant: Sound Health Systems, Inc.
- Decided: Apr 24, 2025 after 269 days
- Product code: QZC (External Mechanical Stimulator For The Relief Of Congestion)
- Device class: 2
- Regulation: 21 CFR 874.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230045 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230045: Sonu, Sound Health Systems, Inc. (2023) Summary page 5.

## Indications for use
Sonu is indicated for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu is a treatment to be used at home by individuals 12 and older.

Source page: https://510kreport.com/device/K242214
Methodology: https://510kreport.com/methodology