510(k) · Cleared
ClearedModel 6110 Iontophoretic Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life-Tech Intl., Inc. · EGJ Device, Iontophoresis, Other Uses
Cleared on Mar 4, 1987 after a 198-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Mar 4, 1987
- Review
- 198 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK863166 Model 6110 Iontophoretic ApplicatorLife-Tech Intl., Inc. · 1987
- Descendant · cites it directly · 4 of its ownK032968 Trsansderm Ionto SystemMattioli Engineering Corp. · 2003
- Descendant · 2 generations on · 3 of its ownK042590 Transderm Ionto System, MK 2Mattioli Engineering Corp. · 2004
- Descendant · 2 generations on · 1 of its ownK061849 MesodermAa Advanced Technology, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK043047 Dynatron Ibox Iontophoresis DeviceDynatronics Corp. · 2005
- Descendant · 2 generations on · 0 of its ownK170291 IontoDCSoterix Medical, Inc. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K032968Trsansderm Ionto SystemMattioli Engineering Corp. · 2003 · cites it directly4descendants
- K042590Transderm Ionto System, MK 2Mattioli Engineering Corp. · 2004 · 2 generations on3descendants
- K061849MesodermAa Advanced Technology, Inc. · 2007 · 2 generations on1descendant
- K043047Dynatron Ibox Iontophoresis DeviceDynatronics Corp. · 2005 · cites it directly1descendant
- K170291IontoDCSoterix Medical, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K863166 | Model 6110 Iontophoretic Applicator | Life-Tech Intl., Inc. | 1987 | — |
| +1 | K032968 | Trsansderm Ionto System | Mattioli Engineering Corp. | 2003 | — |
| +2 | K042590 | Transderm Ionto System, MK 2 | Mattioli Engineering Corp. | 2004 | — |
| +2 | K061849 | Mesoderm | Aa Advanced Technology, Inc. | 2007 | — |
| +1 | K043047 | Dynatron Ibox Iontophoresis Device | Dynatronics Corp. | 2005 | — |
| +2 | K170291 | IontoDC | Soterix Medical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
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?
- Of its descendants, K032968 (Mattioli Engineering Corp., 2003) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K863166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K863166: Model 6110 Iontophoretic Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K863166
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026