# K202913: NeuroCap (Model DEC22)

- Pathway: 510(k) (Traditional)
- Applicant: Memory MD, Inc.
- Decided: Mar 5, 2021 after 157 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: 5 generations back to K780045 (1978). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172866: NeuroCap, Memory MD, Inc. (2018) Summary page 4.
- K162460: WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts, Wavi Co. (2017) Summary page 5.

## Indications for use
The NeuroCap (Model DEC22) is an Electroencephalogram (EEG) electrode array intended for use in routine clinical and research settings where recording of STAT EEGs is desired.

Source page: https://510kreport.com/device/K202913
Methodology: https://510kreport.com/methodology