Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HJB — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
96 daysmedian FDA review time
195 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K930444 | MARCO STANDARD KERATOMETERS | Marco Ophthalmic, Inc. | 1993-08-09 | 195 | 0 |
| K924779 | BURTON KERATOMETER - MODLE 2040 | R.H. Burton Co. | 1993-04-05 | 194 | 0 |
| K864369 | LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER | Heidelberg Instruments | 1986-12-15 | 40 | 0 |
| K864037 | KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER | Kera Corp. | 1986-11-13 | 28 | 0 |
| K852424 | ACUFEX COMPARATIVE SURGICAL KERATOMETER | Acufex Microsurgical, Inc. | 1985-09-11 | 96 | 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