Brainscope Company, Inc.: FDA clearances and approvals
Brainscope Company, Inc. has 7 FDA 510(k) clearances (first 2009, latest 2019), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time: 160 days. Since 2017 its median was 128 days, against 169 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 9 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 144 |
| 2016 | 1 | 160 |
| 2017 | 0 | — |
| 2018 | 2 | 92 |
| 2019 | 2 | 128 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Brainscope Company, Inc.'s cleared 510(k)s took a median 128 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 169 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PIW | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid | 7 | 6 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 1 | 1 |
Review panels
- Neurology (8)
Most recent Brainscope Company, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190815 | BrainScope TBI | PIW | 2019-09-11 | 166 |
| K183241 | BrainScope TBI (Model: Ahead 400) | PIW | 2019-02-19 | 90 |
| K181785 | Modified BrainScope One | PIW | 2018-12-19 | 169 |
| K181179 | BrainScope One | PIW | 2018-05-18 | 16 |
| K161068 | Ahead 300 | PIW | 2016-09-22 | 160 |
| K143643 | Brainscope Ahead 200 | PIW | 2015-05-15 | 144 |
| K082886 | ZOOM-100DC | OLT | 2009-08-10 | 314 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN140025 | De Novo | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid | 2014-11-17 |
Recalls
openFDA lists no recalls under a recalling firm named Brainscope Company, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Brainscope Company, Inc. is the industry lead sponsor of 9 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04279431: Follow-up of MTBI Patients Discharged from the ED Using Standard Clinical Triage Including BrainScope One (Active not recruiting, started 2020-05-25)
- NCT04074486: Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC (Completed, started 2019-10-02)
- NCT03671083: Validation of Brain Function Assessment Algorithm for mTBI/Concussion (Completed, started 2018-10-01)
- NCT03963804: Objective Brain Function Assessment of mTBI/Concussion (Completed, started 2018-06-11)
- NCT02957461: Validation of Brain Function Assessment Algorithm for mTBI/Concussion in College Athletes (Completed, started 2017-02-03)
Frequently asked questions
How many FDA 510(k) clearances does Brainscope Company, Inc. have?
Brainscope Company, Inc. has 7 FDA 510(k) clearances (first 2009, latest 2019), plus 1 De Novo decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Brainscope Company, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Brainscope Company, Inc.'s cleared 510(k)s is 160 days. Since 2017: 128 days, versus 169 days for all cleared 510(k)s in the same product codes.
What devices does Brainscope Company, Inc. make?
Its most frequent FDA product codes are PIW (Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid, 7); OLT (Non-Normalizing Quantitative Electroencephalograph Software, 1).
Has Brainscope Company, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Brainscope Company, Inc. Related entities may recall under other names.
Next steps
- See all 7 Brainscope Company, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PIW, Brainscope Company, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.