Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Amkor Trading Co. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
97 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841561 | HESUNG'S BLOOD DONOR SETS | Amkor Trading Co. | 1984-08-30 | 48 | 0 |
| K841562 | HESUNG BLOOD TRANSFUSION SETS | Amkor Trading Co. | 1984-07-23 | 97 | 0 |
| K841566 | HESUNG DISPOSABLE SYRINGE | Amkor Trading Co. | 1984-07-17 | 91 | 0 |
| K841565 | HESUNG'S HYPERDERMIC NEEDLES | Amkor Trading Co. | 1984-07-17 | 91 | 0 |
| K841563 | HESUNG'S SOLUTION INFUSION SETS | Amkor Trading Co. | 1984-07-17 | 91 | 0 |
| K841564 | HESUNG SCALP VEIN SET | Amkor Trading Co. | 1984-07-17 | 91 | 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