Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
D.O.R.C. Dutch Ophthalmic Research Center (International) · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022-06-14 | 229 | 6 |
| K190875 | EVA, anterior machine, EVA, combined machine, EVA combined m | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2019-09-25 | 174 | 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