# K021986: Brainet

- Pathway: 510(k) (Traditional)
- Applicant: Nicolet Biomedical, Inc.
- Decided: Aug 23, 2002 after 66 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K780045 (1978). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K780045: Electrode Cap, Electro-Cap Intl., Inc. (1978) Summary page 1.

## Indications for use
The Nicolet BraiNet is placed on the scalp to support electroencephalograph (EEG) electrode placement.

Source page: https://510kreport.com/device/K021986
Methodology: https://510kreport.com/methodology