# K103141: Low Adherent Afm AG Dressings

- Pathway: 510(k) (Special)
- Applicant: Milliken Healthcare Products, LLC
- Decided: Jan 21, 2011 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: 5 generations back to K914579 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051445: Milliken Silver Wound Dressings, Milliken Chemical (2005) Summary page 2.

## Indications for use
Low Adherent AFM Ag Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). The Low Adherent AFM Ag Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.

Source page: https://510kreport.com/device/K103141
Methodology: https://510kreport.com/methodology
