Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tucker & Associates · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022256 | SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND | Tucker & Associates | 2004-04-26 | 654 | 0 |
| K980827 | LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING | Tucker & Associates | 1998-05-04 | 62 | 0 |
| K980802 | NITRILE EXAM GLOVE, POWDER-FREE, BLUE | Tucker & Associates | 1998-03-25 | 23 | 0 |
| K970835 | FACE MASK, SURGICAL MASK, NON-STERILE | Tucker & Associates | 1997-09-03 | 196 | 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