Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dioptics — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
97 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903487 | SOLARSHIELDS ENCORE | Dioptics | 1990-11-05 | 97 | 0 |
| K884878 | SOLARETTES | Dioptics | 1989-02-22 | 93 | 0 |
| K884877 | OCUSHIELDS MASKS | Dioptics | 1989-01-10 | 50 | 0 |
| K885163 | DIOPTICS EYESHIELDS | Dioptics | 1988-12-30 | 17 | 0 |
| K884929 | OCCUSHIELDS | Dioptics | 1988-12-15 | 17 | 0 |
| K862719 | SOLARSHIELDS | Dioptics | 1986-08-21 | 35 | 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