# K142834: DiscoverEEG System, Model DE-401

- Pathway: 510(k) (Traditional)
- Applicant: Neurowave Systems, Inc.
- Decided: Jun 23, 2015 after 266 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 K963644 (1996). 27 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092477: NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701, Neurowave Systems, Inc. (2010) Summary page 4.
- K101830: Zmachine, Model DT-100, Consolidated Research of Richmond, Inc. (2011) Summary page 4.

## Most influential descendants
- K213299: Wireless EEG System (2022), 2 descendants of its own
- K192549: Byteflies Kit (2020), 1 descendant of its own
- K254213: Pascall Sensor Unit (PSU1) (2026), 0 descendants of its own
- K251550: NX01 (NX01) (2025), 0 descendants of its own
- K240593: VEEGix EEG System (2024), 0 descendants of its own

## Indications for use
The DiscoverEEG System, Model DE-401 is intended to be used for measuring and recording the electrical activity of a subject’s brain, obtained by placing non-invasive electrodes on the head. The DiscoverEEG, DE-401 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, ICU, ER, clinical settings and at home and for clinical research. The medical use of data acquired by the DiscoverEEG is to be performed under the direction and interpretation of a licensed medical professional. The DiscoverEEG, Model DE-401 does not provide any diagnostic conclusion about the subject's condition.

Source page: https://510kreport.com/device/K142834
Methodology: https://510kreport.com/methodology