# K091013: Silver PU Antibacterial Foam Dressing - Non Adherent and Island

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Solutions Limited
- Decided: Jul 30, 2009 after 112 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 K000051 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063835: Allevyn AG Dressing, Smith & Nephew, Inc. (2007) Summary page 1.
- K071354: Mepilex AG Dressing, Monlycke Health Care (2007) Summary page 1.
- K061554: Mepilex AG Absorbent Silicone-Coated Dressing, Molnlycke Health Care (2007) Summary page 1.

## Indications for use
Silver PU Antibacterial Foam Dressings are indicated for the management of light to moderate exuding partial and full thickness wounds, such as: Decubitus (pressure) ulcers Diabetic ulcers Leg ulcers Graft and donor sites Lacerations and abrasions 1st and 2nd degree burns Trauma wounds (derreal lesions, trauma injuries or incisions) Post-operative surgical wounds The Silver PU Antibacterial Foam Dressings are indicated for external use only

Source page: https://510kreport.com/device/K091013
Methodology: https://510kreport.com/methodology