# K221963: Cumulus Functional Neurophysiology Platform

- Pathway: 510(k) (Traditional)
- Applicant: Cumulus Neuroscience Limited
- Decided: Apr 27, 2023 after 296 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). 46 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K253767: UB ERP System (2026), 0 descendants of its own

## Indications for use
The Cumulus Functional Neurophysiology Platform is intended for the acquisition, display and storage of electroencephalograph (EEG) obtained by placing electrodes on the head of adults and adolescent patients. The EEG signals are time-stamped. The system can be used in the patient’s home or a health care facility.

Source page: https://510kreport.com/device/K221963
Methodology: https://510kreport.com/methodology