# K052019: North Coast Buffered Iontophoresis Electrode

- Pathway: 510(k) (Traditional)
- Applicant: North Coast Medical, Inc.
- Decided: Nov 4, 2005 after 101 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 K912015 (1991). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031053: Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes, Models I20, I30, I40, I50, and I7, Selectivemed Components, Inc. (2003) Summary page 1.
- K932620: RH-806/GS Model Transq (R)2, Iomed, Inc. (1994) Summary page 1.
- K932621: RH-801/GS Model Transq (R)1, Iomed, Inc. (1994) Summary page 1.
- K983484: Dupel B.L.U.E. Small Iontophoresis Electrode, Empi (1998) Summary page 1.

## Most influential descendants
- K060814: Dynatron Ion Iontophoresis Electrode (2006), 1 descendant of its own
- K080580: Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model Small DDS275, Medium DDM325, Large D (2008), 0 descendants of its own

## Indications for use
Iontophoresis is indicated for the administration of soluble salts or other drugs into the body for medical purposes and can be used as an alternative to hypodermic injection.

Source page: https://510kreport.com/device/K052019
Methodology: https://510kreport.com/methodology