Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HLG · 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) |
|---|---|---|---|---|---|
| K920937 | COMPUTERIZED PUPIL | Trek Medical Products, Inc. | 1992-10-02 | 218 | 0 |
| K895609 | PUPIL PATHWAY ANALYZER (PPA) | Pulse Medical Instruments | 1989-11-02 | 45 | 0 |
| K802351 | F110 PHOTO BINOCULAR OPHTHALMOSCOPE | Minami, Tomine & Lew | 1980-12-17 | 83 | 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