510(k) · Cleared
ClearedSTOPWET iontophoresis apparatus (SW01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taiwan Medical Electronics Co., Ltd. · EGJ Device, Iontophoresis, Other Uses
Cleared on Apr 1, 2025 as substantially equivalent to K192749 (Dermadry Laboratories, Inc., 2020) after a 263-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- Apr 1, 2025
- Review
- 263 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K831320 (1983). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK831320 DrionicGeneral Medical Co. · 1983
- 2 generations backK133033 Hidrex PSP1000Hidrex GmbH · 2015 · Recalled
- 1 generation backK192749 DermadryDermadry Laboratories, Inc. · 2020
- This deviceK242041 STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K831320 | Drionic | General Medical Co. | 1983 | — |
| −2 | K133033 | Hidrex PSP1000 | Hidrex GmbH | 2015 | 3 |
| −1 | K192749 | Dermadry | Dermadry Laboratories, Inc. | 2020 | — |
| 0 (this device) | K242041 | STOPWET iontophoresis apparatus (SW01) | Taiwan Medical Electronics Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 EGJ? 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 EGJ device
- #1 K241267 Hidroxa SE30score 8.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K192749 | DermadrySummary page 5…. Using this apparatus in any other way than its intended purpose may be dangerous. Predicate device: Dermadry (K192749), by Dermadry Laboratories Inc. Device description: STOPWET is designed for individuals suffering from hyperhid… | 2020 |
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 42 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All EGJ devicesEGJ Device, Iontophoresis, Other Uses: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · EGJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EGJ
104in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EGJ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EGJ
3in 2025
MAUDE reports naming product code EGJ, 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 | 5 | 104 | 0 | 1 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 21 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
STOPWET is a Tap Water lontophoresis apparatus. Its intended use is to treat hyperhidrosis (excessive sweating) of the hands and feet.
Using this apparatus in any other way than its intended purpose may be dangerous.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242041: STOPWET iontophoresis apparatus (SW01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242041
Report an extraction error
Are you the manufacturer?
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