510(k) · Cleared
ClearedTBD, Empi Buffered Iontophoresis Electroded MDL. 3
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 Nov 15, 1991 after a 193-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 22 later devices descend from it.
- Decided
- Nov 15, 1991
- Review
- 193 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 4 citing it directly.
- This deviceK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
- Descendant · cites it directly · 21 of its ownK970491 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
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K970491Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997 · cites it directly21descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3 | Empi | 1991 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (22)
See all 224 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?
- Of its descendants, K970491 (Empi, 1997) has gone furthest, with 21 descendants of its own.
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 | — |
https://510kreport.com/device/K912015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912015: TBD, Empi Buffered Iontophoresis Electroded MDL. 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912015
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026