# K072946: Hybresis Iontophoresis Drug Delivery System

- Pathway: 510(k) (Special)
- Applicant: Empi
- Decided: Nov 16, 2007 after 30 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: 6 generations back to K912015 (1991). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063465: Champion Iontophoretic Drug Delivery Device, Iomed, Inc. (2007) Summary page 1.

## Indications for use
The Hybresis system 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/K072946
Methodology: https://510kreport.com/methodology