Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Brainscope Company, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
160 daysmedian FDA review time
314 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190815 | BrainScope TBI | Brainscope Company, Inc. | 2019-09-11 | 166 | 0 |
| K183241 | BrainScope TBI (Model: Ahead 400) | Brainscope Company, Inc. | 2019-02-19 | 90 | 0 |
| K181785 | Modified BrainScope One | Brainscope Company, Inc. | 2018-12-19 | 169 | 0 |
| K181179 | BrainScope One | Brainscope Company, Inc. | 2018-05-18 | 16 | 0 |
| K161068 | Ahead 300 | Brainscope Company, Inc. | 2016-09-22 | 160 | 0 |
| K143643 | Brainscope Ahead 200 | Brainscope Company, Inc. | 2015-05-15 | 144 | 0 |
| DEN140025 | BrainScope Ahead 100 | Brainscope Company, Inc. | 2014-11-17 | 89 | 0 |
| K082886 | ZOOM-100DC | Brainscope Company, Inc. | 2009-08-10 | 314 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda