Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EMI · 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) |
|---|---|---|---|---|---|
| K914035 | MINI-MILL | Biomedical Composites, Ltd. | 1992-03-02 | 174 | 0 |
| K912989 | PLANUSTAR AND DENS NOBILIS DENTURE TEETH | Wilde-USA, Inc. | 1991-08-16 | 39 | 0 |
| K851716 | 865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES | Artiberia | 1985-06-11 | 47 | 0 |
| K823676 | DISC NEEDLE SET #TX-8220 | Today'S Machining & Design, Inc. | 1983-01-09 | 33 | 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