Tivic Health Systems, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Tivic Health Systems, Inc.” (first 2019, latest 2019), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 156 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 156 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tivic Health Systems, Inc. took a median 156 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 158 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| QNU | Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion | 1 | 0 |
Review panels
- Ear, Nose and Throat (1)
- Neurology (1)
Most recent Tivic Health Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182025 | ClearUP Sinus Pain Relief | GZJ | 2019-01-02 | 156 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200006 | De Novo | Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion | 2021-03-05 |
Recalls
openFDA lists no recalls under a recalling firm named Tivic Health Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Tivic Health Systems, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03888274: ClearUP Longitudinal Pilot Study (Completed, started 2018-11-29)
- NCT03466879: A User Study of SYNUS Pain Relief Made by Tivic Health Systems (Completed, started 2018-02-02)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tivic Health Systems, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Tivic Health Systems, Inc.” (first 2019, latest 2019), plus 1 De Novo decision, across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tivic Health Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tivic Health Systems, Inc. is 156 days.
Which FDA product codes appear under Tivic Health Systems, Inc.?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 1); QNU (Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion, 1).
Next steps
- See all 1 Tivic Health Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Tivic Health Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.