# K212325: EEG-acp

- Pathway: 510(k) (Traditional)
- Applicant: Somnomedics GmbH
- Decided: Jun 15, 2022 after 324 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 5.

## Indications for use
EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp.

Source page: https://510kreport.com/device/K212325
Methodology: https://510kreport.com/methodology