Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eizo GmbH · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112645 | RADIFORCE LARGE MONITOR SYSTEM | Eizo GmbH | 2011-09-22 | 10 | 0 |
| K103724 | 10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030) | Eizo GmbH | 2011-06-08 | 169 | 0 |
| K081357 | 5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHER | Eizo GmbH | 2008-09-05 | 114 | 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