# K190050: Tech Dots - Adhesive and conductive gel

- Pathway: 510(k) (Traditional)
- Applicant: Spes Medica Srl
- Decided: Jul 19, 2019 after 190 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: 4 generations back to K983964 (1998). 7 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 14 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.

## Most influential descendants
- K192606: SAC2 - Electrode Cream (2020), 2 descendants of its own
- K200402: DR-HO'S Electro Therapy Conductive Gel (2020), 1 descendant of its own
- K222770: Conductive Gel (2022), 0 descendants of its own
- K212325: EEG-acp (2022), 0 descendants of its own
- K212326: AC Cream - Conductive paste (2021), 0 descendants of its own

## Indications for use
Tech Dots are intended for use in clinical and research EEG/EP recordings from humans. They are used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin

Source page: https://510kreport.com/device/K190050
Methodology: https://510kreport.com/methodology