Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
NCF · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062930 | LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | Alcon Research, Ltd. | 2006-11-08 | 41 | 0 |
| K050336 | OPD-STATION SOFTWARE | Nidek, Inc. | 2005-08-24 | 195 | 0 |
| K023249 | ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | Alcon Laboratories, Inc. | 2002-10-18 | 18 | 1 |
| K000637 | CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) | Alcon Laboratories, Inc. | 2000-05-19 | 84 | 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