# K212326: AC Cream - Conductive paste

- Pathway: 510(k) (Traditional)
- Applicant: Spes Medica Srl
- Decided: Dec 1, 2021 after 128 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: 6 generations back to K983964 (1998). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192606: SAC2 - Electrode Cream, Spes Medica Srl (2020) Summary page 4.

## Indications for use
AC Cream - Conductive paste is intended for use in clinical and research EEG/EP recordings from humans. It is 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/K212326
Methodology: https://510kreport.com/methodology