# K260455: New Wave System

- Pathway: 510(k) (Special)
- Applicant: Zeto, Inc.
- Decided: Mar 13, 2026 after 30 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: 10 generations back to K873535 (1987). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233403: Flexset System, Zeto, Inc. (2024) Summary page 5.

## Indications for use
The New Wave system is intended for prescription use in an outpatient healthcare facility or home use to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The New Wave 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. The system is only intended to be used for short-term recordings up to 2.5 hours.

Source page: https://510kreport.com/device/K260455
Methodology: https://510kreport.com/methodology