Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HGF · 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) |
|---|---|---|---|---|---|
| K945179 | BOTTLE COLLECTION SET | Medgyn Products, Inc. | 1995-01-26 | 94 | 0 |
| K905115 | BIOVISION ENDOCULAR PROBE | Douglas James Donaldson Compliance Services | 1991-02-11 | 90 | 0 |
| K904248 | MODEL GLASE 210 HOLMIUM LASER SYSTEM | Charles L. Rose and Co., Inc. | 1990-12-14 | 88 | 0 |
| K890787 | O-020 LASER INDIRECT OPHTHALMOSCOPE | Hgm Medical Laser Systems, Inc. | 1989-03-24 | 37 | 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