510(k) · Cleared
ClearedDupel Iontophoresis Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Empi · EGJ Device, Iontophoresis, Other Uses
Cleared on Jul 15, 1994 after a 953-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Jul 15, 1994
- Review
- 953 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK915444 Dupel Iontophoresis DeviceEmpi · 1994
- Descendant · cites it directly · 3 of its ownK030395 Empi Action Patch Iontophoresis SystemEmpi · 2003
- Descendant · cites it directly · 1 of its ownK043047 Dynatron Ibox Iontophoresis DeviceDynatronics Corp. · 2005
- Descendant · 2 generations on · 0 of its ownK170291 IontoDCSoterix Medical, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK132832 Activapatch ET Iontophoresis PatchActivatek, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK091326 ActivapatchActivatek, Inc. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K030395Empi Action Patch Iontophoresis SystemEmpi · 2003 · cites it directly3descendants
- K043047Dynatron Ibox Iontophoresis DeviceDynatronics Corp. · 2005 · cites it directly1descendant
- K170291IontoDCSoterix Medical, Inc. · 2017 · 2 generations on0descendants
- K132832Activapatch ET Iontophoresis PatchActivatek, Inc. · 2014 · 2 generations on0descendants
- K091326ActivapatchActivatek, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915444 | Dupel Iontophoresis Device | Empi | 1994 | — |
| +1 | K030395 | Empi Action Patch Iontophoresis System | Empi | 2003 | — |
| +1 | K043047 | Dynatron Ibox Iontophoresis Device | Dynatronics Corp. | 2005 | — |
| +2 | K170291 | IontoDC | Soterix Medical, Inc. | 2017 | — |
| +2 | K132832 | Activapatch ET Iontophoresis Patch | Activatek, Inc. | 2014 | — |
| +2 | K091326 | Activapatch | Activatek, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030395 (Empi, 2003) has gone furthest, with 3 descendants 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.
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 | — |
https://510kreport.com/device/K915444 · printed Nov 4, 2026
Cite this page
510(k) Report. “K915444: Dupel Iontophoresis Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K915444
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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