# K083016: Acthyderm

- Pathway: 510(k) (Traditional)
- Applicant: Microlab Americas, Inc.
- Decided: Jun 16, 2009 after 250 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: 4 generations back to K863166 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061849: Mesoderm, Aa Advanced Technology, Inc. (2007) Summary page 1.

## Indications for use
ActhyDerm is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.

Source page: https://510kreport.com/device/K083016
Methodology: https://510kreport.com/methodology