# K993081: IO-Drive

- Pathway: 510(k) (Traditional)
- Applicant: Selectivemed Components, Inc.
- Decided: Mar 3, 2000 after 170 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: 1 generation back to K912014 (1991). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914621: Iontophoresis Device, Modification, Iomed, Inc. (1991)
- K912014: TBD, Empi Buffered Iontophoresis Electrodes MDL. 2, Empi (1991)

## Most influential descendants
- K031053: Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes, Models I20, I30, I40, I50, and I7 (2003), 4 descendants of its own
- 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

## Indications for use
fo-Drive electrode is indicated to introduce ions of soluble salts and other drugs into body.

Source page: https://510kreport.com/device/K993081
Methodology: https://510kreport.com/methodology