# K192549: Byteflies Kit

- Pathway: 510(k) (Traditional)
- Applicant: Byteflies NV
- Decided: Jun 22, 2020 after 279 days
- Product code: OMC (Reduced- 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: 9 generations back to K963644 (1996). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142834: DiscoverEEG System, Model DE-401, Neurowave Systems, Inc. (2015) Summary page 4.

## Most influential descendants
- K251550: NX01 (NX01) (2025), 0 descendants of its own

## Indications for use
The Byteflies Kit is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, and transmit electrical activity of the brain by placing non-invasive electrodes on the head of patients. It acquires, records and transmits two channels of electroencephalogram (EEG) data. The medical use of data acquired by the Byteflies Kit is to be performed under the direction and interpretation of a licensed medical professional. The Byteflies Kit does not provide any diagnostic conclusions about the patient’s condition.

Source page: https://510kreport.com/device/K192549
Methodology: https://510kreport.com/methodology