Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kera Corp. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K901009 | MODEL 2000 INTRAOPERATIVE CORNEASCOPE | Kera Corp. | 1990-05-30 | 86 | 0 |
| K871479 | VIDEOSCAN (TM) | Kera Corp. | 1987-05-22 | 38 | 0 |
| K864037 | KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER | Kera Corp. | 1986-11-13 | 28 | 0 |
| K850665 | CORNEASCOPE MODEL 1200 | Kera Corp. | 1985-03-20 | 28 | 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