Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MLP · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
94 daysmedian FDA review time
175 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261312 | Temporary Keratoprosthesis (QuickSet TKP™) | Eyekon Medical, Inc. | 2026-07-24 | 94 | 0 |
| K910828 | LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS | Ocular Instruments, Inc. | 1991-08-21 | 175 | 0 |
| K902491 | ECKHARDT TEMPORARY KERATOPROSTHESIS | Dutch Ophthalmic USA, Inc. | 1990-06-26 | 21 | 0 |
| K895013 | COBO TEMPORARY KERATOPROSTHESIS | Ocular Instruments, Inc. | 1989-10-31 | 84 | 0 |
| K842856 | LANDERS-FOULKS TEMP. KERATOPROSTHESIS | Ocular Instruments, Inc. | 1984-12-18 | 151 | 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