510(k) · Cleared
ClearedClearUP Sinus Pain Relief
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tivic Health Systems, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jan 2, 2019 as substantially equivalent to K060517 (Lhasa Oms, Inc., 2006) and 1 other predicate after a 156-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Jan 2, 2019
- Review
- 156 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K011935 (2001). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK011935 Rejuvenique Model #RJV10Salton, Inc. · 2001
- 4 generations backK072260 Nuface, Model NU-4003Carol Cole Company · 2007
- 3 generations backK103472 Nuface PlusCarol Cole Company · 2011
- 2 generations backK133823 Nuface Mini DeviceCarol Cole Company · 2014
- 1 generation backK152199 RejuvatoneMDTrophy Skin, Inc. · 2016
- This deviceK182025 ClearUP Sinus Pain ReliefTivic Health Systems, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011935 | Rejuvenique Model #RJV10 | Salton, Inc. | 2001 | — |
| −4 | K072260 | Nuface, Model NU-4003 | Carol Cole Company | 2007 | — |
| −3 | K103472 | Nuface Plus | Carol Cole Company | 2011 | — |
| −2 | K133823 | Nuface Mini Device | Carol Cole Company | 2014 | — |
| −1 | K152199 | RejuvatoneMD | Trophy Skin, Inc. | 2016 | — |
| 0 (this device) | K182025 | ClearUP Sinus Pain Relief | Tivic Health Systems, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060517 | Pointer ExcelSummary page 4…Transcutaneous electrical Class II 21.CFR 882.5890 Neurology nerve stimulator for pain relief 5. Predicate Devices: -Pointer excel by Lhasa Oms, Inc., K060517 -Rejuvatone MD, TSTONEMD by Trophy Skin, Inc. K152199 6. Device Description and Principle of Opera… | 2006 |
| * | K152199 | RejuvatoneMDSummary page 4…or for pain relief 5. Predicate Devices: -Pointer excel by Lhasa Oms, Inc., K060517 -Rejuvatone MD, TSTONEMD by Trophy Skin, Inc. K152199 6. Device Description and Principle of Operation: Page 1 of 10… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K060517.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182025: ClearUP Sinus Pain Relief.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182025
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026