Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OLU · Predicate Candidate Screening
13 FDA 510(k) clearances under this product code; the 50 most recent screened below.
240 daysmedian FDA review time
522 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253015 | Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | VoxNeuro, Inc. | 2026-06-12 | 266 | 0 |
| K240420 | NeuroField Analysis Suite | Neurofield, Inc. | 2024-09-20 | 220 | 0 |
| K222838 | iSyncBrain©-C | iMediSync, Inc. | 2023-03-16 | 177 | 0 |
| K212684 | BrainView QEEG Software | Medeia, Inc. | 2023-01-28 | 522 | 0 |
| K202588 | BNA Platform | Elminda, Ltd. | 2020-12-07 | 90 | 0 |
| K191432 | cortiQ PRO | G.Tec Medical Engineering GmbH | 2020-01-24 | 240 | 0 |
| K171414 | qEEG-Pro | Brainmaster Technologies, Inc. | 2018-07-01 | 412 | 0 |
| K121119 | BNA ANALYSIS SYSTEM | Eiminda , Ltd. | 2014-07-25 | 834 | 0 |
| K112077 | HBIDB - HUMAN BRIAN INDEX SOFTWARE | Corscience GmbH & Co. KG | 2012-03-09 | 232 | 0 |
| K050192 | BRC SOFTWARE PRODUCT | Brc Operations Pty Limited | 2005-10-20 | 266 | 0 |
| K041263 | NEUROGUIDE ANALYSIS SYSTEM | Applied Neuroscience, Inc. | 2004-08-03 | 84 | 0 |
| K974748 | NEUROMETRIC ANALYSIS SYSTEM | Nxlink, Ltd. | 1998-07-10 | 203 | 0 |
| K904294 | QSI 9500 | Quantified Signal Imaging, Inc. | 1991-07-30 | 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