# K042590: Transderm Ionto System, MK 2

- Pathway: 510(k) (Traditional)
- Applicant: Mattioli Engineering Corp.
- Decided: Oct 14, 2004 after 21 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: 2 generations back to K863166 (1987). 3 ancestors in all.
3 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)
- K032968: Trsansderm Ionto System, Mattioli Engineering Corp. (2003) Summary page 1.

## Most influential descendants
- 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 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.

Source page: https://510kreport.com/device/K042590
Methodology: https://510kreport.com/methodology