Argentum Medical, LLC: FDA clearances and approvals
Argentum Medical, LLC has 10 FDA 510(k) clearances (first 2006, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time: 148 days. Since 2017 its median was 168 days, against 233 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 4 | 110 |
| 2015 | 1 | 86 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 234 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 182 |
| 2023 | 0 | — |
| 2024 | 1 | 90 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Argentum Medical, LLC's cleared 510(k)s took a median 168 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 233 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 9 | 9 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 1 | 1 |
Review panels
Most recent Argentum Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241225 | Silverlon® Wound Contact, Burn Contact Dressing | FRO | 2024-07-31 | 90 |
| K221218 | Silverlon Wound Contact, Burn Contact Dressings | FRO | 2022-10-26 | 182 |
| K190343 | Silverlon Wound Contact, Burn Contact Dressings | FRO | 2019-07-18 | 154 |
| K180570 | Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) | FRO | 2019-01-14 | 315 |
| K150256 | SILVERLON BURN CONTACT DRESSINGS | FRO | 2015-04-30 | 86 |
| K143001 | SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING | FRO | 2014-11-07 | 21 |
| K141033 | SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV | OMP | 2014-09-12 | 143 |
| K141573 | SILVERLON ISLAND WOUND DRESSING | FRO | 2014-08-28 | 77 |
| K122817 | SILVERLON ISLAND WOUND DRESSING | FRO | 2014-05-01 | 594 |
| K053590 | SILVERLON CA (CALCIUM ALGINATE) | FRO | 2006-10-06 | 287 |
Recalls
openFDA lists no recalls under a recalling firm named Argentum Medical, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Argentum Medical, LLC have?
Argentum Medical, LLC has 10 FDA 510(k) clearances (first 2006, latest 2024), across 2 product codes in 1 review panel.
How long does FDA take to clear Argentum Medical, LLC's 510(k)s?
The median time from FDA receipt to decision across Argentum Medical, LLC's cleared 510(k)s is 148 days. Since 2017: 168 days, versus 233 days for all cleared 510(k)s in the same product codes.
What devices does Argentum Medical, LLC make?
Its most frequent FDA product codes are FRO (Dressing, Wound, Drug, 9); OMP (Negative Pressure Wound Therapy Powered Suction Pump, 1).
Has Argentum Medical, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Argentum Medical, LLC. Related entities may recall under other names.
Next steps
- See all 10 Argentum Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code FRO, Argentum Medical, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.