De Novo · Granted
GrantedBrainScope Ahead 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainscope Company, Inc. · PIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
Granted on Nov 17, 2014 as a new device type through De Novo after an 89-day review. 8 later devices descend from it.
- Decided
- Nov 17, 2014
- Review
- 89 days
- Class
- Class II
- Product code
- PIW
- Recalls
- None
8 later devices descend from it, 1 citing it directly.
- This deviceDEN140025 BrainScope Ahead 100Brainscope Company, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK143643 Brainscope Ahead 200Brainscope Company, Inc. · 2015
- Descendant · 2 generations on · 6 of its ownK161068 Ahead 300Brainscope Company, Inc. · 2016
- Descendant · 3 generations on · 5 of its ownK181179 BrainScope OneBrainscope Company, Inc. · 2018
- Descendant · 4 generations on · 3 of its ownK183241 BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc. · 2019
- Descendant · 5 generations on · 2 of its ownK190815 BrainScope TBIBrainscope Company, Inc. · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K143643Brainscope Ahead 200Brainscope Company, Inc. · 2015 · cites it directly7descendants
- K161068Ahead 300Brainscope Company, Inc. · 2016 · 2 generations on6descendants
- K181179BrainScope OneBrainscope Company, Inc. · 2018 · 3 generations on5descendants
- K183241BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc. · 2019 · 4 generations on3descendants
- K190815BrainScope TBIBrainscope Company, Inc. · 2019 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN140025 | BrainScope Ahead 100 | Brainscope Company, Inc. | 2014 | — |
| +1 | K143643 | Brainscope Ahead 200 | Brainscope Company, Inc. | 2015 | — |
| +2 | K161068 | Ahead 300 | Brainscope Company, Inc. | 2016 | — |
| +3 | K181179 | BrainScope One | Brainscope Company, Inc. | 2018 | — |
| +4 | K183241 | BrainScope TBI (Model: Ahead 400) | Brainscope Company, Inc. | 2019 | — |
| +5 | K190815 | BrainScope TBI | Brainscope Company, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PIW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PIW device
- #1 K231914 Nurochek-II Systemscore 11.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143643 | Brainscope Ahead 200 | 2015 | 7 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K143643 (Brainscope Company, Inc., 2015) has gone furthest, with 7 descendants of its own.
How does its category compare?
All PIW devicesPIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PIW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PIW
Too few PIW 510(k)s in any year since 2007 to give a median.
Recalls per year · PIW
No recall names PIW since 2007.
Adverse event reports per year · PIW
No MAUDE report names PIW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (336 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN140025 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN140025: BrainScope Ahead 100.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN140025
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026