Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Keeler Optical Products , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
84 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K810403 | KEELER/KONAN SPECULAR MICROSCOPE | Keeler Optical Products , Ltd. | 1981-05-13 | 84 | 0 |
| K801418 | KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT | Keeler Optical Products , Ltd. | 1980-07-21 | 34 | 0 |
| K792255 | NEVYAS AUTOPRESS EYE COMPRESSOR | Keeler Optical Products , Ltd. | 1979-12-11 | 32 | 0 |
| K782141 | LEVIGATOR, KEELER PHOKO | Keeler Optical Products , Ltd. | 1979-01-26 | 30 | 0 |
| K781892 | LOCATOR, FOREIGN BODY | Keeler Optical Products , Ltd. | 1978-12-04 | 26 | 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