Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HOQ · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
130 daysmedian FDA review time
340 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180895 | Alleye | Oculocare Medical AG | 2018-06-27 | 83 | 0 |
| K143211 | myVision Track Model 005 | Vital Art and Science Incorporated | 2015-03-20 | 130 | 0 |
| K121738 | MYVISIONTRACK(TM) | Vital Art and Science Incorporated | 2013-02-22 | 254 | 0 |
| K014044 | MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) | Notal Vision, Inc. | 2002-03-04 | 87 | 0 |
| K874252 | KREDA DISC | Richmond Products, Inc. | 1988-01-27 | 100 | 0 |
| K863429 | MODIFIED DEVICE FOR SELF EXAMINATION OF EYES | Wheel Checkers | 1987-01-20 | 138 | 0 |
| K843227 | MACULAR FUNCTION ANALYZER | Danek Medical, Inc. | 1985-07-22 | 340 | 0 |
| K843702 | APPARATUS & METHODS SELF-EXAM OF EYE | Wheel Checkers | 1985-01-03 | 104 | 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