Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Reichert Ophthalmic Instruments, Div. Leica, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000288 | REICHERT CT200 CONTACT TONOMETER | Reichert Ophthalmic Instruments, Div. Leica, Inc. | 2000-03-23 | 52 | 0 |
| K964290 | EYECHEK | Reichert Ophthalmic Instruments, Div. Leica, Inc. | 1997-01-09 | 73 | 0 |
| K941865 | XPERT NCT | Reichert Ophthalmic Instruments, Div. Leica, Inc. | 1994-09-29 | 164 | 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