510(k) · Cleared
ClearedBrainScope TBI
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
Cleared on Sep 11, 2019 as substantially equivalent to K183241 (Brainscope Company, Inc., 2019) after a 166-day review. Its family tree reaches back 5 generations to 1980. 2 later devices descend from it.
- Decided
- Sep 11, 2019
- Review
- 166 days
- Class
- Class II
- Product code
- PIW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K801604 (1980). 21 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK801604 Pathfinder Electrodiagnostic SystemNicolet Biomedical Instruments · 1980
- 4 generations backK974748 Neurometric Analysis SystemNxlink, Ltd. · 1998
- 3 generations backK161068 Ahead 300Brainscope Company, Inc. · 2016
- 2 generations backK181179 BrainScope OneBrainscope Company, Inc. · 2018
- 1 generation backK183241 BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc. · 2019
- This deviceK190815 BrainScope TBIBrainscope Company, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK231914 Nurochek-II SystemHeadsafe Mfg Pty, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK243426 Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801604 | Pathfinder Electrodiagnostic System | Nicolet Biomedical Instruments | 1980 | — |
| −4 | K974748 | Neurometric Analysis System | Nxlink, Ltd. | 1998 | — |
| −3 | K161068 | Ahead 300 | Brainscope Company, Inc. | 2016 | — |
| −2 | K181179 | BrainScope One | Brainscope Company, Inc. | 2018 | — |
| −1 | K183241 | BrainScope TBI (Model: Ahead 400) | Brainscope Company, Inc. | 2019 | — |
| 0 (this device) | K190815 | BrainScope TBI | Brainscope Company, Inc. | 2019 | — |
| +1 | K231914 | Nurochek-II System | Headsafe Mfg Pty, Ltd. | 2023 | — |
| +2 | K243426 | Nurochek-Pro System | Headsafe Mfg Pty, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1995 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K183241 | BrainScope TBI (Model: Ahead 400)Summary page 5…Neurology Product Codes: PIW, PKQ, OLU Predicate Device: BrainScope TBI (model: Ahead 400) (K183241) 1 Prepared in accordance with 21 CFR § 807.87(h) and 21 CFR § 807.92(c). BrainScop… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231914 | Nurochek-II System | 2023 | 1 |
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?
- The line of descent spans 39 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K231914 (Headsafe Mfg Pty, Ltd., 2023) has gone furthest, with 1 descendant 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. 2019, 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?
• BrainScope TBI is a multi-modal, multi-parameter assessment indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury, and have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion/mild traumatic brain injury (mTBI)). • BrainScope TBI provides a multi-parameter measure (Concussion Index (CI)) to aid in the evaluation of concussion in patients…
Read the full statement (472 words)
• BrainScope TBI is a multi-modal, multi-parameter assessment indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury, and have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion/mild traumatic brain injury (mTBI)).
• BrainScope TBI provides a multi-parameter measure (Concussion Index (CI)) to aid in the evaluation of concussion in patients between the ages of 13–25 years who present with a GCS score of 15 following a head injury within the past 72 hours (3 days), in conjunction with a standard neurological assessment of concussion. The CI is computed from a multivariate algorithm based on the patient’s electroencephalogram (EEG), augmented by neurocognitive measures and selected clinical symptoms.
• The BrainScope TBI Structural Injury Classification (“SIC”) uses brain electrical activity (EEG) to determine the likelihood of structural brain injury visible on head CT for patients between the ages of 18-85 years (have a GCS score of 13 – 15), have sustained a closed head injury within the past 72 hours (3 days) who are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan. Negative likely corresponds to those with no structural brain injury visible on head CT. Positive likely corresponds to those with a structural brain injury visible on head CT. Equivocal may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.
• BrainScope TBI provides a measure of brain function (EEG Brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG), aiding in the evaluation of head injury as part of a multi-modal, multi-parameter assessment, in patients 18-85 years of age (have a GCS score of 13 – 15) who have sustained a closed head injury within the past 72 hours (3 days).
• The BrainScope TBI 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 BrainScope TBI 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.
• BrainScope TBI also provides clinicians with quantitative measures of cognitive performance in patients 13-85 years of age to aid in the assessment of an individual’s level of cognitive function. These measures interact with the CI and can be used stand alone.
• BrainScope TBI 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190815 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190815: BrainScope TBI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190815
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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