Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
HOG · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
97 daysmedian FDA review time
161 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962989 | AMOILS EPITHELIAL SCRUBBER | S. Percy Amoils | 1997-01-09 | 161 | 0 |
| K960261 | PALLIKARIS BRUSH | Alcon Laboratories, Inc. | 1996-03-11 | 53 | 0 |
| K950520 | BURR, CORNEAL, BATTERY-POWERED | Aaron Medical Industries | 1995-05-02 | 85 | 0 |
| K883785 | GY-RO SAFE | Gy-Ro Industry, Inc. | 1989-01-05 | 120 | 0 |
| K834354 | OPHTEC RUST RING REMOVER | Jedmed Instrument Co. | 1984-03-19 | 97 | 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