Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Suzhou 66 Vision Tech Co., Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131711 | YZ3 PORTABLE SLIT LAMP | Suzhou 66 Vision Tech Co., Ltd. | 2014-05-09 | 332 | 0 |
| K052599 | 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11 | Suzhou 66 Vision Tech Co., Ltd. | 2006-11-07 | 412 | 0 |
| K033190 | VISION-TECH YZ SLIT LAMP, MODEL 66 | Suzhou 66 Vision-Tech Co., Ltd. | 2003-12-04 | 64 | 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