Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nidek Technologies Srl — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
169 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113451 | NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING S | Nidek Technologies Srl | 2012-05-08 | 169 | 2 |
| K070231 | ORION | Nidek Technologies Srl | 2007-04-24 | 90 | 0 |
| K061768 | MP-1 MICROPERIMETER | Nidek Technologies Srl | 2006-09-28 | 97 | 0 |
| K023719 | MP-1 MICRO PERIMETER | Nidek Technologies Srl | 2002-12-23 | 48 | 0 |
| K012416 | CONFOSCAN 2 CONFOCAL MICROSCOPE | Nidek Technologies Srl | 2001-10-26 | 88 | 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