510(k) · Cleared
ClearedNaimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402, 201-403 and 201-405
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Naimco, Inc. · EGJ Device, Iontophoresis, Other Uses
Cleared on Apr 22, 2004 as substantially equivalent to K932620 (Iomed, Inc., 1994) and 3 other predicates after a 56-day review. Its family tree reaches back 3 generations to 1991. 5 later devices descend from it.
- Decided
- Apr 22, 2004
- Review
- 56 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K912015 (1991). 8 ancestors in all, the oldest K882554 (1988). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
- 2 generations backK970491 Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997
- 1 generation backK983484 Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998
- This deviceK040495 Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models…Naimco, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK061522 Trivarion Buffered Iontophoresis Electrode SystemActivatek, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK232020 Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK132832 Activapatch ET Iontophoresis PatchActivatek, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK091326 ActivapatchActivatek, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK060579 Comfort/IO Iontophoresis ElectrodesPepin Mfg., Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K061522Trivarion Buffered Iontophoresis Electrode SystemActivatek, Inc. · 2006 · cites it directly2descendants
- K232020Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd. · 2023 · cites it directly0descendants
- K132832Activapatch ET Iontophoresis PatchActivatek, Inc. · 2014 · 2 generations on0descendants
- K091326ActivapatchActivatek, Inc. · 2009 · 2 generations on0descendants
- K060579Comfort/IO Iontophoresis ElectrodesPepin Mfg., Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3 | Empi | 1991 | — |
| −2 | K970491 | Dupel II Buffered Iontophoresis Electrodes | Empi | 1997 | — |
| −1 | K983484 | Dupel B.L.U.E. Small Iontophoresis Electrode | Empi | 1998 | — |
| 0 (this device) | K040495 | Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401… | Naimco, Inc. | 2004 | — |
| +1 | K061522 | Trivarion Buffered Iontophoresis Electrode System | Activatek, Inc. | 2006 | — |
| +1 | K232020 | Iontophoresis Electrodes | Top-Rank Health Care Co., Ltd. | 2023 | — |
| +2 | K132832 | Activapatch ET Iontophoresis Patch | Activatek, Inc. | 2014 | — |
| +2 | K091326 | Activapatch | Activatek, Inc. | 2009 | — |
| +1 | K060579 | Comfort/IO Iontophoresis Electrodes | Pepin Mfg., Inc. | 2006 | — |
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 |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K932620 | RH-806/GS Model Transq (R)2Summary page 1…Trade Name Manufacturer 510(k) Number TransQe Electrodes lomed, Inc. K932620 logel Electrodes lomed, Inc. K932621 Dupel B.L.U.E.… | 1994 |
| * | K932621 | RH-801/GS Model Transq (R)1Summary page 1…TransQe Electrodes lomed, Inc. K932620 logel Electrodes lomed, Inc. K932621 Dupel B.L.U.E. Empi, Inc. K983484 Electrodes… | 1994 |
| * | K983484 | Dupel B.L.U.E. Small Iontophoresis ElectrodeSummary page 1…logel Electrodes lomed, Inc. K932621 Dupel B.L.U.E. Empi, Inc. K983484 Electrodes Meditrode Electrodes Life-Tech, Inc. K882554… | 1998 |
| * | K882554 | Meditrode KitSummary page 1…Empi, Inc. K983484 Electrodes Meditrode Electrodes Life-Tech, Inc. K882554 Page 1 of 2 0… | 1988 |
What descends from it? (5)
3 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 13 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K061522 (Activatek, Inc., 2006) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K932620.
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?
Naimco, Inc. Iontophoresis Drug Delivery Electrodes are indicated to introduce ions of soluble salts or other drugs into the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040495 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040495: Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402, 201-403 and 201-405.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040495
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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