510(k) · Cleared
ClearedMedical Adhesiveonline, LLC. Iontophoresis Drug Delivery Electrodes, Models 23001, 23002, 23003, 23004, and 24001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Adhesiveonline, LLC · EGJ Device, Iontophoresis, Other Uses
Cleared on Jul 7, 2004 as substantially equivalent to K932620 (Iomed, Inc., 1994) and 3 other predicates after a 72-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jul 7, 2004
- Review
- 72 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). No later device cites it as a predicate yet.
- 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 deviceK041101 Medical Adhesiveonline, LLC. Iontophoresis Drug Delivery Electrodes…Medical Adhesiveonline, LLC · 2004
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) | K041101 | Medical Adhesiveonline, LLC. Iontophoresis Drug Delivery Electrodes, Models… | Medical Adhesiveonline, LLC | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 3 | 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 Medit… | 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…E. Empi, Inc. K983484 Electrodes Meditrode Electrodes Life-Tech, Inc. K882554 Page 1 of 2 M A… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
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 5.5 years on median.
- None of the 8 ancestors has a recall.
- 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?
Medical Adhesivesonline, LLC. Iontophoresis Drug Delivery Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041101 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041101: Medical Adhesiveonline, LLC. Iontophoresis Drug Delivery Electrodes, Models 23001, 23002, 23003, 23004, and 24001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041101
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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