510(k) · Cleared
ClearedDermadry
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dermadry Laboratories, Inc. · EGJ Device, Iontophoresis, Other Uses
Cleared on Feb 10, 2020 as substantially equivalent to K133033 (Hidrex GmbH, 2015) after a 133-day review. Its family tree reaches back 2 generations to 1983. 1 later device descends from it.
- Decided
- Feb 10, 2020
- Review
- 133 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K831320 (1983). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK831320 DrionicGeneral Medical Co. · 1983
- 1 generation backK133033 Hidrex PSP1000Hidrex GmbH · 2015 · Recalled
- This deviceK192749 DermadryDermadry Laboratories, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK242041 STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242041STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831320 | Drionic | General Medical Co. | 1983 | — |
| −1 | K133033 | Hidrex PSP1000 | Hidrex GmbH | 2015 | 3 |
| 0 (this device) | K192749 | Dermadry | Dermadry Laboratories, Inc. | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 K242041 STOPWET iontophoresis apparatus (SW01)score 9.7 · 3 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 |
|---|---|---|---|
| * | K133033 | Hidrex PSP1000Summary page 4…Physical Medicine Product Code EGJ 6. Identification of the Predicate Hidrex PSP1000 510(k) Number K133033 7. Indications for Use of the Subject Device This Tap-Water-Iontophoresis device is intended to treat hyperhidrosis (patholog… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242041 | STOPWET iontophoresis apparatus (SW01) | 2025 | 0 |
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 37 years and passes through 3 companies; a new generation was cleared every 31.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K242041 (Taiwan Medical Electronics Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K133033.
How does its category compare?
All EGJ devicesEGJ Device, Iontophoresis, Other Uses: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Dermadry is a Tap Water Iontophoresis device. Its intended use is to treat hyperhidrosis (excessive sweating) of the hands, feet and underarms. Using the device in any other way than its intended purpose may be dangerous.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192749: Dermadry.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192749
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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