# K023612: Silverlon Contact Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Argentum International, LLC
- Decided: Jan 24, 2003 after 88 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K914579 (1992). 5 ancestors in all.
102 later devices descend from it; 10 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981299: Silverlon Contact Wound Dressing, Argentum International, LLC (1998)

## Most influential descendants
- K063069: Silvaklenz Skin and Wound Clenser Solution (2007), 73 descendants of its own
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel (2008), 66 descendants of its own
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser (2009), 37 descendants of its own
- K100918: Vashe Wound Therapy System Model: 9000-0014 (2010), 31 descendants of its own
- K123072: Vashe Wound Therapy Solution (2013), 25 descendants of its own

## Indications for use
For over-the-counter use, SilverlonB Wound Contact Dressing may be used for: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns. Under the supervision of a health care professional, SilverlonB Wound Contact Dressing may be used for the management of SilverlonB Wound Contact Dressings provide an effective barrier to bacterial penetration and are intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).

Source page: https://510kreport.com/device/K023612
Methodology: https://510kreport.com/methodology