# K163062: PHMB Antimicrobial Foam Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Solutions, Ltd.
- Decided: Jul 25, 2017 after 265 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K181197: PHMB Foam Wound Dressing (2018), 5 descendants of its own
- K192463: PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border (2020), 1 descendant of its own
- K190819: Silicone PHMB Foam Wound Dressing (2019), 1 descendant of its own
- K213473: Antimicrobial Gelling Fiber Dressing with PHMB (2023), 0 descendants of its own
- K223310: Antimicrobial Silicone PHMB Foam Wound Dressing (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K163062
Methodology: https://510kreport.com/methodology