510(k) Report

FDA applicant

Argentum Medical, LLC

Geneva, IL10 decisions2006–20240 recalls

FDA records 10 decisions for Argentum Medical, LLC (Geneva, IL) from 2006 to 2024: 10 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and OMP (Negative Pressure Wound Therapy Powered…). Since 2016 its 510(k)s took a median of 168 days from receipt to decision, against 270 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 8 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Argentum Medical”, “Argentum Medical, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Argentum Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2014: 42015: 12019: 22022: 12024: 1
2007high 4 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Argentum Medical, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Argentum Medical, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FRODressing, Wound, Drug9decisions
  • OMPNegative Pressure Wound Therapy Powered Suction Pump1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 168 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 270 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 21 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K122817Silverlon Island Wound DressingArgentum Medical, LLC · 20144cite it
  • K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 20143cite it
  • K190343Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC · 20192cite it
  • K180570Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)Argentum Medical, LLC · 20191cites it
  • K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc. · 20221cites it
  • K053590Silverlon CA (Calcium Alginate)Argentum Medical, LLC · 20061cites it

What has FDA decided for it lately?

  • K241225Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC · 2024
  • K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc. · 2022
  • K190343Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC · 2019
  • K180570Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)Argentum Medical, LLC · 2019
  • K150256Silverlon Burn Contact DressingsArgentum Medical · 2015
  • K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014
  • K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG Antimicrobial Wound…Argentum Medical, LLC · 2014
  • K141573Silverlon Island Wound DressingArgentum Medical · 2014

All 6 as Argentum Medical, LLC →All 3 as Argentum Medical →The one decision as Argentum Medical, Inc. →

Other applicant names beginning “Argentum”

FDA records each applicant name separately; these may or may not be the same firm.

Argentum International, LLC 8