# K032968: Trsansderm Ionto System

- Pathway: 510(k) (Traditional)
- Applicant: Mattioli Engineering Corp.
- Decided: Dec 2, 2003 after 70 days
- Product code: EGJ (Device, Iontophoresis, Other Uses)
- Device class: 2
- Regulation: 21 CFR 890.5525
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K863166 (1987). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913601: Microphor, Life-Tech Intl., Inc. (1994) Summary page 1.
- K863166: Model 6110 Iontophoretic Applicator, Life-Tech Intl., Inc. (1987) Summary page 1.

## Most influential descendants
- K042590: Transderm Ionto System, MK 2 (2004), 3 descendants of its own
- K061849: Mesoderm (2007), 1 descendant of its own
- K083016: Acthyderm (2009), 0 descendants of its own
- K060236: MW-1000 Iontophoretic Drug Delivery Electrode (2006), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K032968
Methodology: https://510kreport.com/methodology