Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QWO — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252041 | Fibresolve (with PCCP) | Imvaria, Inc. | 2025-11-07 | 130 | 0 |
| K241891 | ScreenDx | Imvaria, Inc. | 2025-01-10 | 196 | 0 |
| K242467 | IQ-UIP | Imbio, Inc. | 2024-12-19 | 121 | 0 |
| DEN220040 | Fibresolve | Imvaria, Inc. | 2024-01-12 | 562 | 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