510(k) · Cleared
ClearedDupel II Buffered Iontophoresis Electrodes
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 May 30, 1997 as substantially equivalent to K912015 (Empi, 1991) after a 109-day review. Its family tree reaches back 1 generation to 1991. 21 later devices descend from it.
- Decided
- May 30, 1997
- Review
- 109 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912015 (1991). 21 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
- This deviceK970491 Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997
- Descendant · cites it directly · 20 of its ownK983484 Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998
- Descendant · 2 generations on · 6 of its ownK031115 RH-900Iomed, Inc. · 2003
- Descendant · 2 generations on · 5 of its ownK040495 Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models…Naimco, Inc. · 2004
- Descendant · 2 generations on · 4 of its ownK031053 Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery…Selectivemed Components, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 3 of its ownK033192 RH-950Iomed, Inc. · 2003
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K983484Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998 · cites it directly20descendants
- K031115RH-900Iomed, Inc. · 2003 · 2 generations on6descendants
- K040495Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402…Naimco, Inc. · 2004 · 2 generations on5descendants
- K031053Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes…Selectivemed Components, Inc. · 2003 · 2 generations on4descendants
- K033192RH-950Iomed, Inc. · 2003 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3 | Empi | 1991 | — |
| 0 (this device) | K970491 | Dupel II Buffered Iontophoresis Electrodes | Empi | 1997 | — |
| +1 | K983484 | Dupel B.L.U.E. Small Iontophoresis Electrode | Empi | 1998 | — |
| +2 | K031115 | RH-900 | Iomed, Inc. | 2003 | — |
| +2 | K040495 | Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401… | Naimco, Inc. | 2004 | — |
| +2 | K031053 | Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System… | Selectivemed Components, Inc. | 2003 | 1 |
| +3 | K033192 | RH-950 | Iomed, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3Summary page 1…/Usual Name: Iontophoresis Electrode Trade/Proprietary Name: Dupel® IT Buffered Iontophoresis Electrode System Predicate Device: Empi Buffered Iontophoresis Electrode (K912015) Product Description: The Dupel® IT Buffered Iontophoresis Electrode System consists of an active drug delivery electrode and a… | 1991 |
| † | K903093 | Iontophoresis Device | 1990 |
What descends from it? (21)
See all 213 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?
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 Dupel® I Buffered Iontophoresis Electrodes are designed for use with the Dupel Iontophoresis System (K903093) which 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970491: Dupel II Buffered Iontophoresis Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970491
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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