Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
HOD · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924774 | BURTON AUTOMATIC PROJECTOR - MODEL CP-40 | R.H. Burton Co. | 1993-04-14 | 203 | 0 |
| K891610 | HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER | Keeler Instruments, Inc. | 1989-06-05 | 77 | 0 |
| K831285 | SURGICAL/LID MARGIN COVER & EYELASH- | Richard R. Anthony, M.D. | 1983-06-03 | 44 | 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