# K030887: Lektrogel, Model LK3001

- Pathway: 510(k) (Traditional)
- Applicant: Inmed Ltda.
- Decided: Jun 13, 2003 after 84 days
- Product code: GYB (Media, Electroconductive)
- Device class: 2
- Regulation: 21 CFR 882.1275
- 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 K852956 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852956: Contact Conductive Adhesive Gel Composition, Parker Laboratories, Inc. (1985) Summary page 1.

## Indications for use
LEKTROGELTM is an electroconductive gel media used with external electrodes to reduce the impedance (resistance to alternative current) of the contact between the electrode surface and the skin.

Source page: https://510kreport.com/device/K030887
Methodology: https://510kreport.com/methodology