# K121119: Bna Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Eiminda, Ltd.
- Decided: Jul 25, 2014 after 834 days
- Product code: OLU (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: 5 generations back to K801604 (1980). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041263: Neuroguide Analysis System, Applied Neuroscience, Inc. (2004) Summary page 1.
- K050192: BRC Software Product, Brc Operations Pty Limited (2005) Summary page 1.
- K112077: Hbidb - Human Brian Index Software, Corscience GmbH & Co. KG (2012) Summary page 1.

## Most influential descendants
- K202588: BNA Platform (2020), 1 descendant of its own
- K253015: Cognitive Function Neuroimaging (cfNI) Software (1.0.0) (2026), 0 descendants of its own

## Indications for use
The BNA Analysis System is to be used by qualified medical professionals for the post-hoc statistical analysis of the human electroencephalogram ("EEG"), utilizing evoked response potentials ("ERP"). This device is indicated for use in individuals 14 to 24 years of age. The BNA Analysis System is to be used with the auditory oddball task only.

Source page: https://510kreport.com/device/K121119
Methodology: https://510kreport.com/methodology