Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PAB — 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) |
|---|---|---|---|---|---|
| K252481 | cobas CMV | Roche Molecular Systems, Inc. | 2025-11-03 | 88 | 0 |
| K243485 | Alinity m CMV | Abbott Molecular, Inc. | 2025-07-01 | 235 | 0 |
| K243935 | Aptima CMV Quant Assay | Hologic, Inc. | 2025-01-17 | 28 | 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