Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EKW — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
30 daysmedian FDA review time
90 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871493 | DENTI-TRAY(TM) | Advanced Medical, Inc. | 1987-06-24 | 69 | 0 |
| K870765 | CANNULATED INSTRUMENT CLEANERS | Treace Medical, Inc. | 1987-05-27 | 90 | 0 |
| K862523 | MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS | Walter Lorenz Surgical, Inc. | 1986-08-01 | 30 | 0 |
| K831749 | ENDODONTIC BROACH(76EKN) BARBED BROACH | Union Branch | 1983-07-12 | 50 | 0 |
| K823489 | ENDODONTIC BROACH-BARBED BROACH | Union Broach, Div. Moyco Industries, Inc. | 1982-12-15 | 22 | 0 |
| K800292 | ENDEX BROACH, ENDODONTIC | Ipco Corp. | 1980-02-19 | 8 | 0 |
| K760985 | HAND INSTRUMENTS | Adp Intl., Inc. | 1976-11-15 | 25 | 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