# K202588: BNA Platform

- Pathway: 510(k) (Traditional)
- Applicant: Elminda, Ltd.
- Decided: Dec 7, 2020 after 90 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: 6 generations back to K801604 (1980). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121119: Bna Analysis System, Eiminda, Ltd. (2014) Summary page 4.
- K171414: qEEG-Pro, Brainmaster Technologies, Inc. (2018) Summary page 4.

## Most influential descendants
- K253015: Cognitive Function Neuroimaging (cfNI) Software (1.0.0) (2026), 0 descendants of its own

## Indications for use
The BNA™ Platform is to be used by qualified medical professionals for the post-hoc statistical analysis of the human electroencephalogram ("EEG"), including event-related potentials ("ERPs'). This device is indicated for use in individuals 12 to 85 years of age. The BNA™ Platform is to be used with the Auditory Oddball, Visual Go No-Go (age range of 25 to 85 years), and Eyes-Closed tasks.

Source page: https://510kreport.com/device/K202588
Methodology: https://510kreport.com/methodology