Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QMY — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211463 | Regulora | Metame Health, Inc. | 2021-11-24 | 197 | 0 |
| K211372 | Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) M | Mahana Therapeutics, Inc. | 2021-06-02 | 29 | 0 |
| DEN200029 | Parallel | Mahana Therapeutics, Inc. | 2020-11-25 | 209 | 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