Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medeia, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212684 | BrainView QEEG Software | Medeia, Inc. | 2023-01-28 | 522 | 0 |
| K192753 | NeuralScan System | Medeia, Inc. | 2020-03-17 | 169 | 0 |
| K191266 | VitalScan ANS | Medeia, Inc. | 2020-01-15 | 250 | 0 |
| K150804 | QBioScan | Medeia, Inc. | 2015-10-19 | 207 | 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