Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QWB — 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) |
|---|---|---|---|---|---|
| K253453 | Metrix COVID Test; Metrix COVID Test Pro | Aptitude Medical Systems, Inc. | 2026-08-07 | 305 | 0 |
| K232643 | Cue COVID-19 Molecular Test | Cue Health, Inc. | 2023-11-28 | 90 | 0 |
| DEN220028 | Cue COVID-19 Molecular Test | Cue Health, Inc. | 2023-06-06 | 400 | 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