510(k) · Cleared
ClearedTrivarion Buffered Iontophoresis Electrode System
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 Aug 1, 2006 as substantially equivalent to K040495 (Naimco, Inc., 2004) and 1 other predicate after a 60-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.
- Decided
- Aug 1, 2006
- Review
- 60 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K912015 (1991). 9 ancestors in all, the oldest K882554 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
- 3 generations backK970491 Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997
- 2 generations backK983484 Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998
- 1 generation backK040495 Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models…Naimco, Inc. · 2004
- This deviceK061522 Trivarion Buffered Iontophoresis Electrode SystemActivatek, Inc. · 2006
- 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3 | Empi | 1991 | — |
| −3 | K970491 | Dupel II Buffered Iontophoresis Electrodes | Empi | 1997 | — |
| −2 | K983484 | Dupel B.L.U.E. Small Iontophoresis Electrode | Empi | 1998 | — |
| −1 | K040495 | Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401… | Naimco, Inc. | 2004 | — |
| 0 (this device) | K061522 | Trivarion Buffered Iontophoresis Electrode System | Activatek, Inc. | 2006 | — |
| +1 | K132832 | Activapatch ET Iontophoresis Patch | Activatek, Inc. | 2014 | — |
| +1 | K091326 | Activapatch | Activatek, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K040495 | Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402…Summary page 1…Date of preparation of this Summary: 5-31-2006 C. Name of Predicate Devices to which equivalence is claimed: * Naimco Iontoplus Buffered lontophoresis Electrode (k040495) * lomed TransQ E iontophoresis Electrode (k932630) The ActivaTek Trivarion lontophoresis Electrode is substantially… | 2004 |
| * | K932620 | RH-806/GS Model Transq (R)2 Our reading of the summary gave K932630, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Iomed TransQ E iontophoresis Electrode”. | 1994 |
What descends from it? (2)
2 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 15 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K132832 (Activatek, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K040495.
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 Trivarion Buffered Iontophoresis Electrode System 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/K061522 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061522: Trivarion Buffered Iontophoresis Electrode System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061522
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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