510(k) · Cleared
ClearedDupel B.L.U.E. Small Iontophoresis Electrode
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 Dec 28, 1998 as substantially equivalent to K970491 (Empi, 1997) and 3 other predicates after an 84-day review. Its family tree reaches back 2 generations to 1991. 20 later devices descend from it.
- Decided
- Dec 28, 1998
- Review
- 84 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K912015 (1991). 4 ancestors in all. 20 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
- 1 generation backK970491 Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997
- This deviceK983484 Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998
- Descendant · cites it directly · 6 of its ownK031115 RH-900Iomed, Inc. · 2003
- Descendant · cites it directly · 5 of its ownK040495 Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models…Naimco, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK031053 Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery…Selectivemed Components, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 3 of its ownK033192 RH-950Iomed, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK030395 Empi Action Patch Iontophoresis SystemEmpi · 2003
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K031115RH-900Iomed, Inc. · 2003 · cites it directly6descendants
- K040495Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402…Naimco, Inc. · 2004 · cites it directly5descendants
- K031053Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes…Selectivemed Components, Inc. · 2003 · cites it directly4descendants
- K033192RH-950Iomed, Inc. · 2003 · 2 generations on3descendants
- K030395Empi Action Patch Iontophoresis SystemEmpi · 2003 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3 | Empi | 1991 | — |
| −1 | K970491 | Dupel II Buffered Iontophoresis Electrodes | Empi | 1997 | — |
| 0 (this device) | K983484 | Dupel B.L.U.E. Small Iontophoresis Electrode | Empi | 1998 | — |
| +1 | K031115 | RH-900 | Iomed, Inc. | 2003 | — |
| +1 | K040495 | Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401… | Naimco, Inc. | 2004 | — |
| +1 | K031053 | Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System… | Selectivemed Components, Inc. | 2003 | 1 |
| +2 | K033192 | RH-950 | Iomed, Inc. | 2003 | — |
| +1 | K030395 | Empi Action Patch Iontophoresis System | Empi | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K970491 | Dupel II Buffered Iontophoresis ElectrodesSummary page 1…roprietary Name: Dupel B.L.U.E Small Iontophoresis Electrode Common Name: Iontophoresis Electrode B. Name of Predicate Devices e Empi Dupel II Iontophoresis Electrodes K970491 ¢ Jomed Trans Q1 (RH-800) K914621 and K925806 e Empi Iontophoresis Buffered Electrodes K912015 C. Device Description The Dupel®… | 1997 |
| * | K914621 | Iontophoresis Device, ModificationSummary page 1…ll Iontophoresis Electrode Common Name: Iontophoresis Electrode B. Name of Predicate Devices e Empi Dupel II Iontophoresis Electrodes K970491 ¢ Jomed Trans Q1 (RH-800) K914621 and K925806 e Empi Iontophoresis Buffered Electrodes K912015 C. Device Description The Dupel® Buffered Iontophoresis Electrode S… | 1991 |
| * | K925806 | RH-801, Model TransqSummary page 1…esis Electrode Common Name: Iontophoresis Electrode B. Name of Predicate Devices e Empi Dupel II Iontophoresis Electrodes K970491 ¢ Jomed Trans Q1 (RH-800) K914621 and K925806 e Empi Iontophoresis Buffered Electrodes K912015 C. Device Description The Dupel® Buffered Iontophoresis Electrode System consis… | 1994 |
| * | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3Summary page 1…de B. Name of Predicate Devices e Empi Dupel II Iontophoresis Electrodes K970491 ¢ Jomed Trans Q1 (RH-800) K914621 and K925806 e Empi Iontophoresis Buffered Electrodes K912015 C. Device Description The Dupel® Buffered Iontophoresis Electrode System consists of an active drug delivery electrode and a pa… | 1991 |
What descends from it? (20)
See all 208 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031115 | RH-900 | 2003 | 6 |
| K040495 | Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402… | 2004 | 5 |
| K031053 | Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes… | 2003 | 4 |
| K030395 | Empi Action Patch Iontophoresis System | 2003 | 3 |
| K052019 | North Coast Buffered Iontophoresis Electrode | 2005 | 2 |
| K070427 | Dupel Transport Iontophoresis System | 2007 | 0 |
| K041101 | Medical Adhesiveonline, LLC. Iontophoresis Drug Delivery Electrodes, Models 23001… | 2004 | 0 |
| K991991 | Dupel Iontophoresis System | 1999 | 0 |
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 7 years and passes through 1 company; a new generation was cleared every 5.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K031115 (Iomed, Inc., 2003) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K970491.
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?
Iontophoresis drug delivery systems are indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983484 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983484: Dupel B.L.U.E. Small Iontophoresis Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983484
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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