# K983964: Batch #6060 Conductive Gel

- Pathway: 510(k) (Traditional)
- Applicant: Skylark Device Co., Ltd.
- Decided: Dec 9, 1998 after 33 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
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022006: Conductive Gel (2002), 10 descendants of its own
- K033052: Conductive Eeg Electrolyte (2003), 9 descendants of its own
- K111717: Electro-Gel (2012), 8 descendants of its own
- K190050: Tech Dots - Adhesive and conductive gel (2019), 6 descendants of its own
- K192606: SAC2 - Electrode Cream (2020), 2 descendants of its own

## Indications for use
FOR USE WITH TENS (TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS) AND EMS (ELECTRICAL MUSCLE STIMULATORS). CONDUCTIVE GEL IS USED WITH EXTERNAL ELECTRODES TO REDUCE THE IMPEDACE OF THE CONTACT BETWEEN THE ELECTRODE SURFACE AND THE SKIN.

Source page: https://510kreport.com/device/K983964
Methodology: https://510kreport.com/methodology