# K060237: CMB Antimicrobial Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Silverleaf Medical Products, Inc.
- Decided: Jun 15, 2006 after 136 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: 2 generations back to K914579 (1992). 6 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 11 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 1.
- K973855: IT Hydrocolloid with Zinc, Innovative Technologies, Ltd. (1997) Summary page 1.
- K033814: Bard Soft Mesh, Models 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007, C.R. Bard, Inc. (2004) Summary page 1.

## Most influential descendants
- K081977: Prosit Wound Treatment Device (2008), 3 descendants of its own
- K130350: Procellera (2013), 2 descendants of its own
- K160783: Procellera (2016), 1 descendant of its own
- K180533: Procellera Composite Antibacterial Wound Dressing (2018), 0 descendants of its own

## Indications for use
The CMB Antimicrobial Dressing is indicated for professional use as an antimicrobial barrier for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, bums and donor and recipient graft sites.

Source page: https://510kreport.com/device/K060237
Methodology: https://510kreport.com/methodology