Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EHJ — 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) |
|---|---|---|---|---|---|
| K911111 | MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS | Vermont Diamond Instruments | 1991-11-19 | 257 | 0 |
| K873002 | MIN-IDENTOFLEX | Centrix, Inc. | 1987-08-17 | 13 | 0 |
| K790640 | HOWMEDICA BRASS CENTER DISC | E.C. Moore Co. | 1979-05-01 | 32 | 0 |
| K771658 | IDENTOFLEX | Cavitron Corp. | 1977-09-12 | 13 | 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