# K221959: Q21

- Pathway: 510(k) (Traditional)
- Applicant: Neurofield, Inc.
- Decided: Aug 31, 2023 after 422 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K873535 (1987). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201819: Cadwell Apollo System, Cadwell Industries, Inc. (2020) Summary page 4.
- K192753: NeuralScan System, Medeia, Inc. (2020) Summary page 4.

## Indications for use
The NeuroField Q21 System is indicated for prescription use to acquire, record, transmit, and display physiological data for electroencephalographic (EEG) studies of patients of all ages.

Source page: https://510kreport.com/device/K221959
Methodology: https://510kreport.com/methodology