Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HLL · 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) |
|---|---|---|---|---|---|
| K222484 | Retitrack | C. Light Technologies, Inc. | 2023-05-09 | 265 | 0 |
| K152890 | SACCADOMETER PLUS, SACCADOMETER ADVANCED | Ober Consulting Sp. Z.O.O. | 2016-08-11 | 316 | 0 |
| K033949 | VARILUX VISIONPRINT SYSTEM (VPS) | Essilor Intl. | 2004-07-02 | 196 | 0 |
| K872111 | ORTHOTONE | Orthotone Corp. | 1988-11-16 | 534 | 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