# K141033: Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG Antimicrobial Wound Contact Negativ

- Pathway: 510(k) (Traditional)
- Applicant: Argentum Medical, LLC
- Decided: Sep 12, 2014 after 143 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K914575 (1991). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050261: V.a.C. Granufoam Silver Protection Dressing, Kinetic Concepts, Inc. (2005) Summary page 5.
- K041642: V.a.C. Granufoam Silver Dressing, Kinetic Concepts, Inc. (2005) Summary page 5.
- K080275: NPD 1000 Negative Pressure Wound Therapy System, Iasis Medical, Inc. (2008) Summary page 5.
- K981299: Silverlon Contact Wound Dressing, Argentum International, LLC (1998) Summary page 5.
- K122817: Silverlon Island Wound Dressing, Argentum Medical, LLC (2014). Cleared while this submission was under review Summary page 5.

## Indications for use
Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and the Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing are intended to provide moist wound environment and are used for the management of chronic, acute, surgical, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic}, partial-thickness burns, flaps and grafts; when used in conjunction with an NPWT pump that is intended to be used for negative pressure wound therapy (NPWT), the NPWT system is indicated for patients who benefit from wound management therapy via the application of negative pressure wound therapy for removal of fluids and excess exudates, infectious material, and tissue debris which may promote wound healing. It provides a non-adherent, conformable, antimicrobial barrier and may help reduce infection when placed under reticulated foam, gauze, or other wound fillers. Silverlon® Fenestrated Wound Contact Dressings may be cut or overlapped to fit any wound size.

Source page: https://510kreport.com/device/K141033
Methodology: https://510kreport.com/methodology