# K181466: Cadwell Zenith System

- Pathway: 510(k) (Traditional)
- Applicant: Cadwell Industries, Inc.
- Decided: Sep 1, 2018 after 89 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: 17 generations back to K941811 (1994). 212 ancestors in all.
No later device cites it as a predicate yet.
0 of 213 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143440: Natus Quantum, Natus Medical Incorporated (2015) Summary page 4.
- K180181: Natus Quantum, Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) (2018) Summary page 4.
- K162199: Cascade IOMAX Intraoperative Monitor, Cadwell Industries, Inc. (2017) Summary page 4.

## Indications for use
Zenith is an electroneurodiagnostic device that accepts, measures, displays, records, and stores electrical activity of the brain via scalp and intracranial electroencephalography (EEG) signals, and, utilizing an integrated switch matrix, relays stimulation signals to the patient. It can obtain, display and store electrophysiological data from the central nervous system, generated either spontaneously or elicited by well-defined stimuli. The data is used to perform neurodiagnostic evaluations, including EEG and direct cortical stimulation. Zenith is used with Cadwell acquisition software. Zenith is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing on patients of all ages.

Source page: https://510kreport.com/device/K181466
Methodology: https://510kreport.com/methodology