# K031053: Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes, Models I20, I30, I40, I50, and I7

- Pathway: 510(k) (Traditional)
- Applicant: Selectivemed Components, Inc.
- Decided: May 20, 2003 after 48 days
- Product code: EGJ (Device, Iontophoresis, Other Uses)
- Device class: 2
- Regulation: 21 CFR 890.5525
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K912015 (1991). 10 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993081: IO-Drive, Selectivemed Components, Inc. (2000) 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.
- K882554: Meditrode Kit, Life-Tech Intl., Inc. (1988) Summary page 1.

## Most influential descendants
- K052019: North Coast Buffered Iontophoresis Electrode (2005), 2 descendants of its own
- 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
- K060579: Comfort/IO Iontophoresis Electrodes (2006), 0 descendants of its own

## Recalls of this device
- Mar 15, 2005 · Not classified · Z-0799-05: The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.

## Indications for use
Selective Med Components, Inc., Buffered Iontophoresis Drug Delivery System Electrodes are indicated to introduce ions of soluble salts or other drugs into the body.

Source page: https://510kreport.com/device/K031053
Methodology: https://510kreport.com/methodology