Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DGD · 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) |
|---|---|---|---|---|---|
| K946266 | FERRITIN CONTROL - LEVEL 1, 2, 3 | Clinical Controls, Inc. | 1995-02-10 | 49 | 0 |
| K881345 | IMX FERRITIN | Abbott Laboratories | 1988-05-11 | 42 | 0 |
| K830229 | ROENTGENOGRAPHY SET | Mallinckrodt Critical Care | 1983-03-09 | 44 | 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