510(k) · Cleared
ClearedMW-1000 Iontophoretic Drug Delivery Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iomed, Inc. · EGJ Device, Iontophoresis, Other Uses
Cleared on Mar 31, 2006 as substantially equivalent to K932621 (Iomed, Inc., 1994) and 1 other predicate after a 60-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Mar 31, 2006
- Review
- 60 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K863166 (1987). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK863166 Model 6110 Iontophoretic ApplicatorLife-Tech Intl., Inc. · 1987
- 2 generations backK032968 Trsansderm Ionto SystemMattioli Engineering Corp. · 2003
- 1 generation backK042590 Transderm Ionto System, MK 2Mattioli Engineering Corp. · 2004
- This deviceK060236 MW-1000 Iontophoretic Drug Delivery ElectrodeIomed, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K863166 | Model 6110 Iontophoretic Applicator | Life-Tech Intl., Inc. | 1987 | — |
| −2 | K032968 | Trsansderm Ionto System | Mattioli Engineering Corp. | 2003 | — |
| −1 | K042590 | Transderm Ionto System, MK 2 | Mattioli Engineering Corp. | 2004 | — |
| 0 (this device) | K060236 | MW-1000 Iontophoretic Drug Delivery Electrode | Iomed, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K932621 | RH-801/GS Model Transq (R)1Summary page 1…-1000 lontophoretic Drug Delivery Electrode Common Name: Iontophoresis Drug Delivery Electrode B. Name of Predicate Device(s) * lontophoresis Device:K932621 lontophoresis Drug Delivery Electrode IOMED, Inc. RH-801/GS lontophoretic Drug Delivery Electrode * lontophoresis De… | 1994 |
| * | K042590 | Transderm Ionto System, MK 2Summary page 1…* lontophoresis Device:K932621 lontophoresis Drug Delivery Electrode IOMED, Inc. RH-801/GS lontophoretic Drug Delivery Electrode * lontophoresis Device: K042590 lontophoresis Drug Delivery System Mattioli Engineering Transderm lonto System, MK 2 C. Device Description An ionto… | 2004 |
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 19 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 5 ancestors has a recall.
- 5 other devices also cite its predicate K932621.
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?
Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060236: MW-1000 Iontophoretic Drug Delivery Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060236
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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