Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Dutch Ophthalmic Research Center International BV · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160591 | D.O.R.C. Disposable Cryo Probe | Dutch Ophthalmic Research Center International BV | 2017-01-23 | 328 | 0 |
| K142877 | EVA,anterior machine, EVA, combined machine, EVA combined ma | Dutch Ophthalmic Research Center International BV | 2015-03-13 | 163 | 0 |
| K081877 | ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS | Dutch Ophthalmic Research Center International BV | 2009-01-05 | 187 | 0 |
| K062895 | XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII | Dutch Ophthalmic Research Center International BV | 2006-10-13 | 16 | 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