Amkor Trading Co.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Amkor Trading Co.” (first 1984, latest 1984), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 91 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 3 | 3 |
| BRZ | Set, Blood Transfusion | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Amkor Trading Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841561 | HESUNG'S BLOOD DONOR SETS | BRZ | 1984-08-30 | 48 |
| K841562 | HESUNG BLOOD TRANSFUSION SETS | FPA | 1984-07-23 | 97 |
| K841566 | HESUNG DISPOSABLE SYRINGE | FMF | 1984-07-17 | 91 |
| K841565 | HESUNG'S HYPERDERMIC NEEDLES | FMI | 1984-07-17 | 91 |
| K841564 | HESUNG SCALP VEIN SET | FPA | 1984-07-17 | 91 |
| K841563 | HESUNG'S SOLUTION INFUSION SETS | FPA | 1984-07-17 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Amkor Trading Co..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Amkor Trading Co.?
FDA lists 6 510(k) clearances under the applicant name “Amkor Trading Co.” (first 1984, latest 1984), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Amkor Trading Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amkor Trading Co. is 91 days.
Which FDA product codes appear under Amkor Trading Co.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 3); BRZ (Set, Blood Transfusion, 1); FMF (Syringe, Piston, 1).
Next steps
- See all 6 Amkor Trading Co. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Amkor Trading Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.