510(k) · Cleared
Recalled · Class III · 2017Hidrex PSP1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hidrex GmbH · EGJ Device, Iontophoresis, Other Uses
Cleared on Apr 8, 2015 as substantially equivalent to K964208 (R. A. Fischer Co. Corp., 1997) and 1 other predicate after a 559-day review. Its family tree reaches back 1 generation to 1983. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 8, 2015
- Review
- 559 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K831320 (1983). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK831320 DrionicGeneral Medical Co. · 1983
- This deviceK133033 Hidrex PSP1000Hidrex GmbH · 2015
- Descendant · cites it directly · 1 of its ownK192749 DermadryDermadry Laboratories, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK242041 STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK241267 Hidroxa SE30Hidroxa Medical AB · 2024
- Descendant · cites it directly · 0 of its ownK191436 SaalioSaalmann Medical GmbH & Co. KG · 2019
Most influential descendants
Showing 4 of 4 · See all- K192749DermadryDermadry Laboratories, Inc. · 2020 · cites it directly1descendant
- K242041STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd. · 2025 · 2 generations on0descendants
- K241267Hidroxa SE30Hidroxa Medical AB · 2024 · cites it directly0descendants
- K191436SaalioSaalmann Medical GmbH & Co. KG · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831320 | Drionic | General Medical Co. | 1983 | — |
| 0 (this device) | K133033 | Hidrex PSP1000 | Hidrex GmbH | 2015 | — |
| +1 | K192749 | Dermadry | Dermadry Laboratories, Inc. | 2020 | — |
| +2 | K242041 | STOPWET iontophoresis apparatus (SW01) | Taiwan Medical Electronics Co., Ltd. | 2025 | — |
| +1 | K241267 | Hidroxa SE30 | Hidroxa Medical AB | 2024 | — |
| +1 | K191436 | Saalio | Saalmann Medical GmbH & Co. KG | 2019 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K964208 | MD-1A Galvanic UnitSummary page 4…Predicate Device Information: We claim substantial equivalence for the subject device in intended use, design and function to the predicate device MD-1A (K964208) by R.A. Fischer CO. CORP and to the predicate device Drionic (K831320) by General Medical Company. Intended Use / Indi… | 1997 |
| * | K831320 | DrionicSummary page 4…e subject device in intended use, design and function to the predicate device MD-1A (K964208) by R.A. Fischer CO. CORP and to the predicate device Drionic (K831320) by General Medical Company. Intended Use / Indication for Use:… | 1983 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2017 | Class III | Z-1238-2017 | Error in labeling | The device was reclassified from a class III device to a class II device and there are new documentation requirements. |
| Jan 30, 2017 | Class III | Z-1237-2017 | Error in labeling | The device was reclassified from a class III device to a class II device and there are new documentation requirements. |
| Jan 30, 2017 | Class III | Z-1236-2017 | Error in labeling | The device was reclassified from a class III device to a class II device and there are new documentation requirements. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K192749 (Dermadry Laboratories, Inc., 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EGJ devicesEGJ Device, Iontophoresis, Other Uses: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
This Tap-Water-Iontophoresis device is intended to treat hyperhidrosis (pathological sweating) affecting hands, feet, and underarms. Any other use or usage beyond this scope is considered un-intended use and may have dangerous consequences.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133033 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133033: Hidrex PSP1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133033
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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