# DEN140025: BrainScope Ahead 100

- Pathway: De Novo (Direct)
- Applicant: Brainscope Company, Inc.
- Decided: Nov 17, 2014 after 89 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
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K143643: Brainscope Ahead 200 (2015), 7 descendants of its own
- K161068: Ahead 300 (2016), 6 descendants of its own
- 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

## Indications for use
The Ahead® 100, consisting of two models, i.e., the Ahead® M-100 and the Ahead® CV-100, 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, but should not be used as a substitute for a CT scan. This device is to be used for this purpose in patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury with a Glasgow Coma Scale score (GCS) of 13-15, and are between the ages of 18-80 years. A negative BrainScope® Classification may correspond to brain electrical activity consistent with no structural brain injury visible on head CT in patients presenting as a mild traumatic brain injury, within 24 hours of injury. A positive BrainScope® Classification corresponds to brain electrical activity that may be present in both patients with or without a structural brain injury visible on head CT. A positive BrainScope® Classification does not establish the presence of a structural brain injury visible on head CT. The Ahead® 100 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® 100 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. The Ahead® M-100 model additionally stores and displays an electronic version of the Military Acute Concussion Evaluation (MACE) cognitive assessment and user-entered responses to the MACE questions. There is no interaction between EEG-related functionality, including analyzing and displaying brain electrical activity, and the function of storing and displaying MACE information. The Ahead® 100 is intended for use by physicians, or under the direction of a physician, who have been trained in the use of the device. The Ahead® 100 is a prescription use device.

Source page: https://510kreport.com/device/DEN140025
Methodology: https://510kreport.com/methodology