Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sunny Sunglasses — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
148 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940627 | WENZHOU IMPORT AND EXPORT CORP | Sunny Sunglasses | 1994-07-12 | 148 | 0 |
| K940628 | JIHN MEI OPTICAL CO. | Sunny Sunglasses | 1994-07-12 | 148 | 0 |
| K940924 | SUNGLASSES | Sunny Sunglasses | 1994-07-12 | 134 | 0 |
| K940626 | CLEVER OPTICAL INDUSTRIES LTD | Sunny Sunglasses | 1994-07-12 | 148 | 0 |
| K940629 | YEOU NAN SUNGLASSES CO | Sunny Sunglasses | 1994-07-12 | 148 | 0 |
| K940625 | CHEN SHUENG ENTERPRISE CO. | Sunny Sunglasses | 1994-07-12 | 148 | 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