# K210974: High Performance Antimicrobial Gelling Fiber with Silver

- Pathway: 510(k) (Special)
- Applicant: Advanced Medical Solutions, Ltd.
- Decided: May 12, 2021 after 41 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 K914604 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183645: Silver High Performance Dressing, Advanced Medical Solutions, Ltd. (2019) Summary page 4.

## Indications for use
Under the supervision of a healthcare professional, High Performance Antimicrobial Gelling Fiber with Silver can be used in the management of moderate to heavily exuding chronic and acute wounds. The antimicrobial dressing is indicated for use on the following wounds; * Pressure ulcers (partial and full thickness) * Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) + Diabetic foot ulcers « Surgical wounds that heal by primary intent such as dermatological and surgical incisions * Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites * Traumatic wounds

Source page: https://510kreport.com/device/K210974
Methodology: https://510kreport.com/methodology