Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HMR · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
53 daysmedian FDA review time
662 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053475 | OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 | Refractec, Inc. | 2006-03-03 | 79 | 0 |
| K925606 | OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS | Chiron Vision Corp. | 1994-08-29 | 662 | 0 |
| K872747 | LASER CENTERING DEVICE | Innomed Corp. | 1987-09-04 | 53 | 0 |
| K863663 | OPHTHALMIC SURGICAL OCULAR MARKERS | Myocure, Inc. | 1986-10-20 | 32 | 0 |
| K861535 | OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU | CooperVision, Inc. | 1986-05-14 | 20 | 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