Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
SEI · 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) |
|---|---|---|---|---|---|
| K260046 | Elecsys Anti-HBc II | Roche Diagnostics | 2026-04-07 | 90 | 0 |
| K260049 | Elecsys Anti-HBc IgM | Roche Diagnostics | 2026-04-07 | 90 | 0 |
| K254059 | Access anti-HBc IgM | Beckman Coulter, Inc. | 2026-03-13 | 86 | 0 |
| K253687 | Access anti-HBc Total | Beckman Coulter, Inc. | 2026-02-19 | 90 | 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