Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Optomed OY — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
162 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora | Optomed OY | 2018-04-05 | 52 | 0 |
| K163021 | HAAG-STREIT FUNDUS MODULE 300 | Optomed OY | 2017-04-11 | 162 | 0 |
| K132186 | OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMA | Optomed OY | 2013-12-18 | 156 | 0 |
| K110986 | OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 | Optomed OY | 2011-05-16 | 38 | 0 |
| K092056 | OPTOMED SMARTSCOPE, MODEL M3-1 EY1 | Optomed OY | 2009-10-01 | 86 | 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