Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CHN — 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) |
|---|---|---|---|---|---|
| K091741 | TINA-QUANT CERULOPLASMIN | Roche Diagnostics | 2010-03-18 | 275 | 0 |
| K063655 | DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIB | Dade Behring, Inc. | 2007-02-15 | 69 | 0 |
| K062114 | CERULOPLASMIN, MODEL 2055953 | Roche Diagnostics Corp. | 2007-01-31 | 191 | 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