# K172735: WR19 System

- Pathway: 510(k) (Traditional)
- Applicant: Zeto, Inc.
- Decided: Apr 17, 2018 after 218 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: 8 generations back to K873535 (1987). 21 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131383: X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software, Advanced Brain Monitoring, Inc. (2013) Summary page 4.

## Most influential descendants
- K233403: Flexset System (2024), 1 descendant of its own
- K260455: New Wave System (2026), 0 descendants of its own
- K220056: iSyncWave (2022), 0 descendants of its own

## Indications for use
The WR19 System is intended for prescription use in a health care facility or clinical research environment to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns. The WR19 System requires operation by a healthcare professional familiar with EEG. The WR19 System acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), accelerometer, photic sensor, external trigger signals and video.

Source page: https://510kreport.com/device/K172735
Methodology: https://510kreport.com/methodology