# DEN200006: ClearUP Sinus Relief

- Pathway: De Novo (Direct)
- Applicant: Tivic Health Systems, Inc.
- Decided: Mar 5, 2021 after 392 days
- Product code: QNU (Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion)
- Device class: 2
- Regulation: 21 CFR 874.6000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
ClearUP Sinus Relief device is a transcutaneous electrical nerve stimulator that electrically stimulates the skin overlying the paranasal sinuses and is intended to be used for the temporary relief of moderate to severe congestion. ClearUP Sinus Relief is a treatment to be used at home by individuals 18 and older.

Source page: https://510kreport.com/device/DEN200006
Methodology: https://510kreport.com/methodology