510(k) · Cleared
ClearedEmpi Action Patch Iontophoresis System
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 Apr 8, 2003 as substantially equivalent to K992708 (Birch Point Medical, Inc., 2000) and 3 other predicates after a 62-day review. Its family tree reaches back 3 generations to 1991. 3 later devices descend from it.
- Decided
- Apr 8, 2003
- Review
- 62 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K912015 (1991). 7 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
- 2 generations backK970491 Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997
- 1 generation backK983484 Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998
- This deviceK030395 Empi Action Patch Iontophoresis SystemEmpi · 2003
- Descendant · cites it directly · 0 of its ownK132832 Activapatch ET Iontophoresis PatchActivatek, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK091326 ActivapatchActivatek, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK070427 Dupel Transport Iontophoresis SystemEmpi · 2007
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3 | Empi | 1991 | — |
| −2 | K970491 | Dupel II Buffered Iontophoresis Electrodes | Empi | 1997 | — |
| −1 | K983484 | Dupel B.L.U.E. Small Iontophoresis Electrode | Empi | 1998 | — |
| 0 (this device) | K030395 | Empi Action Patch Iontophoresis System | Empi | 2003 | — |
| +1 | K132832 | Activapatch ET Iontophoresis Patch | Activatek, Inc. | 2014 | — |
| +1 | K091326 | Activapatch | Activatek, Inc. | 2009 | — |
| +1 | K070427 | Dupel Transport Iontophoresis System | Empi | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 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? (4)
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 |
|---|---|---|---|
| * | K992708 | IontopatchSummary page 1…resis Device B. Date of preparation of this Summary: January 3 1,2003 C. Name of Predicate Devices to which equivalence is claimed: 0 Birch Point IontoPatch K992708 0 Empi Dupel B.L.U.E. Iontophoresis Electrode K983484 0 Empi Dupel Dual-Chamber Iontophoresis System K9 15444… | 2000 |
| * | K983484 | Dupel B.L.U.E. Small Iontophoresis ElectrodeSummary page 1…ry 3 1,2003 C. Name of Predicate Devices to which equivalence is claimed: 0 Birch Point IontoPatch K992708 0 Empi Dupel B.L.U.E. Iontophoresis Electrode K983484 0 Empi Dupel Dual-Chamber Iontophoresis System K9 15444 Empi Buffered Iontophoresis Electrodes K9 12015 The… | 1998 |
| * | K915444 | Dupel Iontophoresis DeviceSummary page 1…ce is claimed: 0 Birch Point IontoPatch K992708 0 Empi Dupel B.L.U.E. Iontophoresis Electrode K983484 0 Empi Dupel Dual-Chamber Iontophoresis System K9 15444 Empi Buffered Iontophoresis Electrodes K9 12015 The Empi Action Patch is substantially equivalent to the identified… | 1994 |
| * | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3Summary page 1…0 Empi Dupel B.L.U.E. Iontophoresis Electrode K983484 0 Empi Dupel Dual-Chamber Iontophoresis System K9 15444 Empi Buffered Iontophoresis Electrodes K9 12015 The Empi Action Patch is substantially equivalent to the identified Empi Dupel iontophoresis devices in intended use, m… | 1991 |
What descends from it? (3)
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?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 4.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K132832 (Activatek, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K992708.
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 | — |
What is it indicated for?
The Empi Action Patch Iontophoresis System is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030395: Empi Action Patch Iontophoresis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030395
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