510(k) · Cleared
ClearedActivapatch ET Iontophoresis Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Activatek, Inc. · EGJ Device, Iontophoresis, Other Uses
Cleared on Feb 13, 2014 as substantially equivalent to K030395 (Empi, 2003) and 2 other predicates after a 156-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Feb 13, 2014
- Review
- 156 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K912015 (1991). 15 ancestors in all, the oldest K882554 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
- 4 generations backK970491 Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997
- 3 generations backK983484 Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998
- 2 generations backK031115 RH-900Iomed, Inc. · 2003
- 1 generation backK033192 RH-950Iomed, Inc. · 2003
- This deviceK132832 Activapatch ET Iontophoresis PatchActivatek, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3 | Empi | 1991 | — |
| −4 | K970491 | Dupel II Buffered Iontophoresis Electrodes | Empi | 1997 | — |
| −3 | K983484 | Dupel B.L.U.E. Small Iontophoresis Electrode | Empi | 1998 | — |
| −2 | K031115 | RH-900 | Iomed, Inc. | 2003 | — |
| −1 | K033192 | RH-950 | Iomed, Inc. | 2003 | — |
| 0 (this device) | K132832 | Activapatch ET Iontophoresis Patch | Activatek, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 4 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K030395 | Empi Action Patch Iontophoresis SystemSummary page 2…807.92(a)(3)] The ActivaPatch ET lontophoresis Patch uses similar technology and physical output fled characteristics as the following predicate devices: K030395 EMPI Action Patch K06 1522 Activatek Trivarion lontophoresis Electrode K03 3192 lomed RH-950 lontophoresis Patch E.… | 2003 |
| * | K061522 | Trivarion Buffered Iontophoresis Electrode SystemSummary page 2…atch ET lontophoresis Patch uses similar technology and physical output fled characteristics as the following predicate devices: K030395 EMPI Action Patch K06 1522 Activatek Trivarion lontophoresis Electrode K03 3192 lomed RH-950 lontophoresis Patch E. Device Description [21 CFR 807.9… | 2006 |
| * | K033192 | RH-950Summary page 2…ysical output fled characteristics as the following predicate devices: K030395 EMPI Action Patch K06 1522 Activatek Trivarion lontophoresis Electrode K03 3192 lomed RH-950 lontophoresis Patch E. Device Description [21 CFR 807.92(a)(4)] The Activatek ActivaPatch ET lontophoresis… | 2003 |
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 23 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 2 other devices also cite its predicate K030395.
How does its category compare?
All EGJ devicesEGJ Device, Iontophoresis, Other Uses: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The Activatek ActivaPatch ET Iontophoresis Patch is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132832 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132832: Activapatch ET Iontophoresis Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132832
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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