# K223310: Antimicrobial Silicone PHMB Foam Wound Dressing

- Pathway: 510(k) (Special)
- Applicant: Advanced Medical Solutions Limited
- Decided: Apr 5, 2023 after 159 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 K163062 (2017). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190819: Silicone PHMB Foam Wound Dressing, Advanced Medical Solutions, Ltd. (2019) Summary page 4.

## Indications for use
Antimicrobial Silicone PHMB Foam Wound Dressings are indicated for use in the management of • post-surgical incisions, • pressure sores, • venous stasis ulcers, • diabetic ulcers, • donor sites, • abrasions, • lacerations, • superficial and partial thickness burns, • dermatologic disorders, • other wounds inflicted by trauma and, • as a secondary dressing or cover dressing for packed wounds.

Source page: https://510kreport.com/device/K223310
Methodology: https://510kreport.com/methodology