# K233403: Flexset System

- Pathway: 510(k) (Traditional)
- Applicant: Zeto, Inc.
- Decided: Apr 30, 2024 after 209 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: 9 generations back to K873535 (1987). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172735: WR19 System, Zeto, Inc. (2018) Summary page 5.
- K131383: X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software, Advanced Brain Monitoring, Inc. (2013) Summary page 5.

## Most influential descendants
- K260455: New Wave System (2026), 0 descendants of its own

## Indications for use
The Flexset system is intended for prescription use in a healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Flexset system acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), orientation sensor data, photic sensor data, external trigger signals and video.

Source page: https://510kreport.com/device/K233403
Methodology: https://510kreport.com/methodology