Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HQH · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
106 daysmedian FDA review time
298 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952538 | ROBERT B. SCOTT PLASTIC ARTIFICAL | Robert B. Scott Ocularists of Florida, Inc. | 1995-06-26 | 26 | 0 |
| K945270 | CUSTOM ARTIFICIAL HUMAN EYES | Daniel T Acosta | 1995-05-30 | 214 | 0 |
| K946226 | CUSTOM OCULAR PROSTHESIS | Frank Tanaka, Ocularist, Inc. | 1995-03-22 | 90 | 0 |
| K923167 | THE NISSEL ARTIFICIAL EYE | Nissel , Ltd. | 1992-09-02 | 65 | 0 |
| K904962 | EYE ARTIFICIAL CUSTOM | Midwest Eye Laboratories, Inc. | 1991-08-30 | 298 | 0 |
| K791923 | SCLERAL POWDER | Ocularists , Ltd. | 1980-01-10 | 106 | 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