# K161068: Ahead 300

- Pathway: 510(k) (Traditional)
- Applicant: Brainscope Company, Inc.
- Decided: Sep 22, 2016 after 160 days
- Product code: PIW (Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid)
- Device class: 2
- Regulation: 21 CFR 882.1450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K801604 (1980). 18 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143643: Brainscope Ahead 200, Brainscope Company, Inc. (2015) Summary page 4.
- K150154: ANAM Test System: Military Battery, Vista Lifesciences, Inc. (2015) Summary page 4.
- K974748: Neurometric Analysis System, Nxlink, Ltd. (1998) Summary page 4.

## Most influential descendants
- K181179: BrainScope One (2018), 5 descendants of its own
- K183241: BrainScope TBI (Model: Ahead 400) (2019), 3 descendants of its own
- K190815: BrainScope TBI (2019), 2 descendants of its own
- K231914: Nurochek-II System (2023), 1 descendant of its own
- K243426: Nurochek-Pro System (2025), 0 descendants of its own

## Indications for use
The Ahead 300 is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head CT, who sustained a closed head injury within 72 hours, present with a Glasgow Coma Scale score (GCS) of 13-15, and are between the ages of 18-85 years. The Ahead 300 should not be used as a substitute for a CT scan. The Ahead 300 device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient’s forehead. The Ahead 300 calculates and displays raw measures for the following standard QEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of EEG signals for interpretation by a qualified user. A negative Ahead 300 Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with no structural brain injury visible on head CT. A positive Ahead 300 Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with a structural brain injury visible on head CT. An equivocal Ahead 300 Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation. The Ahead 300 provides a measure of brain function (EEG Brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram(EEG). The Ahead 300 also provides clinicians with quantitative measures of cognitive performance to aid in the assessment of an individual’s level of cognitive function. These measures do not interact with any other device measures, and are stand alone. The Ahead 300 also stores and displays electronic versions of standardized clinical assessment tools that should be used in accordance with the assessment tools’ general instructions. These tools do not interact with any other device measures, and are stand alone.

Source page: https://510kreport.com/device/K161068
Methodology: https://510kreport.com/methodology