Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QWR — 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) |
|---|---|---|---|---|---|
| K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test | Roche Molecular Systems, Inc. | 2025-04-11 | 165 | 0 |
| K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat | Roche Molecular Systems, Inc. | 2023-12-04 | 353 | 0 |
| K221925 | ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | 2023-08-10 | 405 | 2 |
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