510(k) · Cleared
ClearedTrsansderm Ionto System
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 Dec 2, 2003 as substantially equivalent to K913601 (Life-Tech Intl., Inc., 1994) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1987. 4 later devices descend from it.
- Decided
- Dec 2, 2003
- Review
- 70 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K863166 (1987). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK863166 Model 6110 Iontophoretic ApplicatorLife-Tech Intl., Inc. · 1987
- This deviceK032968 Trsansderm Ionto SystemMattioli Engineering Corp. · 2003
- Descendant · cites it directly · 3 of its ownK042590 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 · 2 generations on · 0 of its ownK060236 MW-1000 Iontophoretic Drug Delivery ElectrodeIomed, Inc. · 2006
Most influential descendants
Showing 4 of 4 · See all- K042590Transderm Ionto System, MK 2Mattioli Engineering Corp. · 2004 · cites it directly3descendants
- K061849MesodermAa Advanced Technology, Inc. · 2007 · cites it directly1descendant
- K083016ActhydermMicrolab Americas, Inc. · 2009 · 2 generations on0descendants
- K060236MW-1000 Iontophoretic Drug Delivery ElectrodeIomed, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863166 | Model 6110 Iontophoretic Applicator | Life-Tech Intl., Inc. | 1987 | — |
| 0 (this device) | K032968 | Trsansderm Ionto System | Mattioli Engineering Corp. | 2003 | — |
| +1 | 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 | — |
| +2 | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K913601 | MicrophorSummary page 1…Manufacturer Product Name 510(k) No. Life-Tech, Inc. Microphor® K913601 Life-Tech, Inc. I ontophor® II K863166 II. DEVICE DESCRIPTION… | 1994 |
| * | K863166 | Model 6110 Iontophoretic ApplicatorSummary page 1…Life-Tech, Inc. Microphor® K913601 Life-Tech, Inc. I ontophor® II K863166 II. DEVICE DESCRIPTION The TRANSDERM IONTO System consists of a probe, power supply/support, and a di… | 1987 |
What descends from it? (4)
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?
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 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/K032968 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032968: Trsansderm Ionto System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032968
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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