# K092477: NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701

- Pathway: 510(k) (Traditional)
- Applicant: Neurowave Systems, Inc.
- Decided: Oct 29, 2010 after 443 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: 7 generations back to K963644 (1996). 24 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082886: Zoom-100DC, Brainscope Company, Inc. (2009) Summary page 1.
- K072382: Model I-2000 Monitor, Infinite Biomedical Technologies (2008) Summary page 1.

## Most influential descendants
- K142834: DiscoverEEG System, Model DE-401 (2015), 5 descendants of its own
- 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

## Indications for use
The NeuroFAST Monitoring System, Model NF-201 is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the head. The NeuroFAST NF-201 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, [CU, ER, clinical settings and for clinical research. The NeuroFAST Monitor is to be used under the direction and interpretation of a licensed medical professional. The NeuroFAST Monitoring System, Model NF-201 does not provide any diagnostic conclusion about the patient's condition.

Source page: https://510kreport.com/device/K092477
Methodology: https://510kreport.com/methodology