Argentum International, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Argentum International, LLC” (first 1998, latest 2007), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 236 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 7 | 7 |
| KMF | Bandage, Liquid | 1 | 1 |
Review panels
Most recent Argentum International, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984207 | SILVERLON DIRECT PRESSURE WOUND DRESSING | KMF | 2007-03-19 | 3037 |
| K984205 | SILVERLON ADHESIVE STRIP | FRO | 2007-03-19 | 3037 |
| K984204 | SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP | FRO | 2007-03-19 | 3037 |
| K023612 | SILVERLON CONTACT WOUND DRESSING | FRO | 2003-01-24 | 88 |
| K023609 | SILVERLON ADHESIVE STRIP | FRO | 2003-01-17 | 81 |
| K984210 | SILVERLON WOUND PACKING STRIPS | FRO | 1999-09-24 | 304 |
| K984208 | SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD | FRO | 1999-02-22 | 90 |
| K981299 | SILVERLON CONTACT WOUND DRESSING | FRO | 1998-09-25 | 169 |
Recalls
openFDA lists no recalls under a recalling firm named Argentum International, LLC.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Argentum Medical, LLC (6 510(k)s)
- Argentum Medical (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Argentum International, LLC?
FDA lists 8 510(k) clearances under the applicant name “Argentum International, LLC” (first 1998, latest 2007), across 2 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 Argentum International, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Argentum International, LLC is 236 days.
Which FDA product codes appear under Argentum International, LLC?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 7); KMF (Bandage, Liquid, 1).
Next steps
- See all 8 Argentum International, LLC clearances with predicates and recalls
- Run predicate analysis for product code FRO, Argentum International, LLC'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.