# K141316: Cognision Eeg/EP System

- Pathway: 510(k) (Traditional)
- Applicant: Neuronetrix Solutions
- Decided: Feb 13, 2015 after 269 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- 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). 38 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 46 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.
- K112052: Carefusion Nicolet Edx, Carefusion 209, Inc. (2012) Summary page 4.
- K962447: Equinox Digital Eeg System, Physiometrix, Inc. (1996) Summary page 4.

## Most influential descendants
- K171781: eVox System (2017), 6 descendants of its own
- K192753: NeuralScan System (2020), 3 descendants of its own
- K221963: Cumulus Functional Neurophysiology Platform (2023), 1 descendant of its own
- K253767: UB ERP System (2026), 0 descendants of its own
- K240420: NeuroField Analysis Suite (2024), 0 descendants of its own

## Indications for use
The COGNISION System is for use by qualified clinical professionals in private practice offices or small clinical settings for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and auditory evoked potentials (AEP) information.

Source page: https://510kreport.com/device/K141316
Methodology: https://510kreport.com/methodology