Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JYJ · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
114 daysmedian FDA review time
270 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904469 | EYEOPENER | Kc Medical Industries | 1991-06-28 | 270 | 0 |
| K884974 | ACCESSORY TO EYEDROP GUIDE | Suredrop, Inc. | 1989-03-24 | 114 | 0 |
| K874569 | SUREDROP EYEDROP GUIDE | Suredrop, Inc. | 1988-05-03 | 180 | 0 |
| K833606 | IMPLANT MEASURING GAUGE | Microtek Medical, Inc. | 1984-01-03 | 83 | 0 |
| K801938 | RHINOMETER | Aztec Medical Products, Inc. | 1980-09-09 | 28 | 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