# K212787: GT5 conductive & abrasive gel

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Greentek Pty, Ltd.
- Decided: Nov 8, 2021 after 68 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: 5 generations back to K983964 (1998). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111717: Electro-Gel, Electro-Cap Intl., Inc. (2012) Summary page 4.
- K190050: Tech Dots - Adhesive and conductive gel, Spes Medica Srl (2019) Summary page 4.
- K970694: Model 1700, Hydro Prep, Physiometrix, Inc. (1997) Summary page 4.
- K885306: Nuprep, Weaver & Co. (1989) Summary page 5.

## Indications for use
GTS5 conductive & abrasive gel is intended for use in clinical and research EEG/EP recordings from humans. It can be not only used as skin-prep gel to abrade the skin surface lightly in order to reduce impedance (resistance to alternating current) efficiently, but also used as the conductor between the scalp and the external electrodes to reduce impedance between the electrode surface and the skin. GT5 conductive & abrasive gel is not intended for use with stimulating electrodes.

Source page: https://510kreport.com/device/K212787
Methodology: https://510kreport.com/methodology