# K050086: Brennen Medical Silver Glucan Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Brennen Medical, Inc.
- Decided: Feb 17, 2006 after 400 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: 4 generations back to K914579 (1992). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955453: Acticoat Silver Coated Dressing, Westaim Technologies, Inc. (1996) Summary page 2.
- K981299: Silverlon Contact Wound Dressing, Argentum International, LLC (1998) Summary page 2.
- K983833: Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-Adhesive, Westaim Biomedical, Inc. (1998) Summary page 2.
- K992221: Acticoat Primary Antimicrobial Dressing, Westaim Biomedical, Inc. (2000) Summary page 2.
- K000051: Acticoat Foam Dressing, Westaim Biomedical, Inc. (2000) Summary page 2.
- K001519: Acticoat 7 Dressing, Westaim Biomedical, Inc. (2000) Summary page 2.
- K002466: Acticoat Composite Dressing, Westaim Biomedical, Inc. (2001) Summary page 2.
- K964241: Brennen Medical Glucan II Wound Dressing, Brennen Medical, Inc. (1996) Summary page 2.

## Indications for use
Silver Glucan Wound Dressing ts an effective barrier 1o bacterial and candida penerration. The dressing, may be used for partial and full thickness wounds including decubitus ulcers. venous stasis ulcers, diabetic uleers. tirst and sccond degree buns, donor sites. and surgical wounds. Silver Glucan dressings miv be used over partial thickness wounds. debrided wounds. and as a temporary covering fur full (hickness and erafled wounds.

Source page: https://510kreport.com/device/K050086
Methodology: https://510kreport.com/methodology