Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HJG · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
51 daysmedian FDA review time
210 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933633 | LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPM | Gracefully Yours, Inc. | 1994-02-22 | 210 | 0 |
| K915340 | MENTOR HORIZON LOW VISION MAGNIFIER | Mentor O & O, Inc. | 1992-03-30 | 158 | 0 |
| K920069 | MAGNI-CAM | Innoventions, Inc. | 1992-03-02 | 55 | 0 |
| K892351 | MAGNILINK SYSTEM 602 | Coburn Optical Ind., Inc. | 1989-05-26 | 51 | 0 |
| K892347 | MAGNILINK SYSTEM 101 | Coburn Optical Ind., Inc. | 1989-05-26 | 51 | 0 |
| K892348 | MAGNILINK SYSTEM 201 | Coburn Optical Ind., Inc. | 1989-05-26 | 51 | 0 |
| K892350 | MAGNILINK SYSTEM 402/5 | Coburn Optical Ind., Inc. | 1989-05-26 | 51 | 0 |
| K892349 | MAGNILINK SYSTEM 209 | Coburn Optical Ind., Inc. | 1989-05-26 | 51 | 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