# DEN230045: Sonu

- Pathway: De Novo (Direct)
- Applicant: Sound Health Systems, Inc.
- Decided: Dec 4, 2023 after 171 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K242214: Sonu (2025), 0 descendants of its own

## 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 22 and older.

Source page: https://510kreport.com/device/DEN230045
Methodology: https://510kreport.com/methodology