510(k) · Cleared
ClearedTransderm Ionto System, MK 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mattioli Engineering Corp. · EGJ Device, Iontophoresis, Other Uses
Cleared on Oct 14, 2004 as substantially equivalent to K032968 (Mattioli Engineering Corp., 2003) after a 21-day review. Its family tree reaches back 2 generations to 1987. 3 later devices descend from it.
- Decided
- Oct 14, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K863166 (1987). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK863166 Model 6110 Iontophoretic ApplicatorLife-Tech Intl., Inc. · 1987
- 1 generation backK032968 Trsansderm Ionto SystemMattioli Engineering Corp. · 2003
- This deviceK042590 Transderm Ionto System, MK 2Mattioli Engineering Corp. · 2004
- Descendant · cites it directly · 1 of its ownK061849 MesodermAa Advanced Technology, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK083016 ActhydermMicrolab Americas, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK060236 MW-1000 Iontophoretic Drug Delivery ElectrodeIomed, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K863166 | Model 6110 Iontophoretic Applicator | Life-Tech Intl., Inc. | 1987 | — |
| −1 | K032968 | Trsansderm Ionto System | Mattioli Engineering Corp. | 2003 | — |
| 0 (this device) | K042590 | Transderm Ionto System, MK 2 | Mattioli Engineering Corp. | 2004 | — |
| +1 | K061849 | Mesoderm | Aa Advanced Technology, Inc. | 2007 | — |
| +2 | K083016 | Acthyderm | Microlab Americas, Inc. | 2009 | — |
| +1 | K060236 | MW-1000 Iontophoretic Drug Delivery Electrode | Iomed, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K032968 | Trsansderm Ionto SystemSummary page 1…Manufacturer Product Name 5 10(k) No. Mattioli Engineering TRANSDERM IONTO K032968 Corporation System II. DEVICE DESCRIPTION The TRANSDERM IONTO System MK 2 cons… | 2003 |
What descends from it? (3)
2 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 17 years and passes through 2 companies; a new generation was cleared every 16.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K061849 (Aa Advanced Technology, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K032968.
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 TRANSDERM IONTO System MK 2 is a powered iontophoresis drug delivery system that is indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042590: Transderm Ionto System, MK 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042590
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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