# K110967: Enterprise Electrophysiology System

- Pathway: 510(k) (Traditional)
- Applicant: Neuralynx, Inc.
- Decided: Jun 30, 2011 after 85 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: 2 generations back to K042626 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060523: Neuroport Neural Signal Processing System, Cyberkinetics, Inc. (2006) Summary page 2.
- K042626: Neuroport Neural Signal Processor (NSP) System, Cyberkinetics, Inc. (2005) Summary page 5.

## Indications for use
The intended use of the Neuralynx Enterprise Electrophysiology System is for temporary (<30 days) recording and monitoring of brain electrical activity.

Source page: https://510kreport.com/device/K110967
Methodology: https://510kreport.com/methodology