Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HJA · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
101 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K901523 | VKG 1000, VIDEO KERATOGRAPH | The Sanborn Co. | 1990-06-27 | 86 | 0 |
| K893968 | VKG 2000 VIDEO KERATOMETER | Technitex, Inc. | 1989-09-11 | 101 | 0 |
| K842128 | AMERICAN MEDICAL OPTICS PHOTOKERATO | American Medical Optics | 1984-08-07 | 70 | 0 |
| K830290 | DORC CONTACT/PHOTO DERATOSCOPE | Jedmed Instrument Co. | 1983-03-09 | 41 | 0 |
| K781650 | TERRY KERATOMETER | Clifford M. Terry, M.C. | 1978-10-17 | 20 | 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