Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HOI — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
56 daysmedian FDA review time
147 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943613 | NIL | Sing Wah International Enterprises , Ltd. | 1994-09-21 | 56 | 0 |
| K930435 | SPECTACLE FRAMES | Venis DI A. Vendrame | 1993-09-20 | 237 | 0 |
| K931328 | PYRAMID SUNGLASSES/PYRAMID READING GLASSES | Pyramid | 1993-08-10 | 147 | 0 |
| K910329 | SUNGLASSES | Cutler & Gross Sloan Optical , Ltd. | 1991-03-12 | 46 | 0 |
| K854854 | SYSTEMS OF SIGHT LOW VISION EYEWARE | Int'L Eye Care, Inc. | 1986-02-04 | 61 | 0 |
| K844716 | MAGNIFYING SPECTACLES W/PLASTIC LENSES | Gazelle Corp. | 1985-01-03 | 30 | 0 |
| K844038 | VISITEC MAGNIFYING SPECTACLES | Visitec Co. | 1984-11-29 | 44 | 0 |
| K842835 | BRILLETTE MODEL | Cillus Company, Inc. | 1984-11-21 | 124 | 0 |
| K820732 | LA VEL LATERAL VIEW EXTENSION LENS | Peter M. Tolliver | 1982-05-03 | 47 | 0 |
| K813548 | UVEX MINI-SPECS | Bacou USA, Inc. and Uvex Safety, Inc. | 1982-03-02 | 71 | 0 |
| K801733 | FENZL RETICLE | Robert E. Fenzl, M.D. | 1980-09-16 | 53 | 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