# K182025: ClearUP Sinus Pain Relief

- Pathway: 510(k) (Traditional)
- Applicant: Tivic Health Systems, Inc.
- Decided: Jan 2, 2019 after 156 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K011935 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060517: Pointer Excel, Lhasa Oms, Inc. (2006) Summary page 4.
- K152199: RejuvatoneMD, Trophy Skin, Inc. (2016) Summary page 4.

## Indications for use
The Tivic Health ClearUP(TM) Sinus Pain Relief device is intended to be used for the temporary relief of sinus pain associated with Allergic Rhinitis.

Source page: https://510kreport.com/device/K182025
Methodology: https://510kreport.com/methodology