Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Argentum Medical, LLC · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
287 daysmedian FDA review time
594 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241225 | Silverlon® Wound Contact, Burn Contact Dressing | Argentum Medical, LLC | 2024-07-31 | 90 | 0 |
| K190343 | Silverlon Wound Contact, Burn Contact Dressings | Argentum Medical, LLC | 2019-07-18 | 154 | 0 |
| K180570 | Silverlon Island Wound Dressing, Silverlon Wound Pad Dressin | Argentum Medical, LLC | 2019-01-14 | 315 | 0 |
| K141033 | SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRES | Argentum Medical, LLC | 2014-09-12 | 143 | 0 |
| K122817 | SILVERLON ISLAND WOUND DRESSING | Argentum Medical, LLC | 2014-05-01 | 594 | 0 |
| K053590 | SILVERLON CA (CALCIUM ALGINATE) | Argentum Medical, LLC | 2006-10-06 | 287 | 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