# K180533: Procellera Composite Antibacterial Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Vomaris Wound Care, Inc.
- Decided: Dec 10, 2018 after 285 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: 6 generations back to K914579 (1992). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160783: Procellera, Vomaris Innovations, Inc. (2016) Summary page 4.
- K130350: Procellera, Vomaris Innovations, Inc. (2013) Summary page 4.
- K081977: Prosit Wound Treatment Device, Silverleaf Medical Products, Inc. (2008) Summary page 4.
- K060237: CMB Antimicrobial Dressing, Silverleaf Medical Products, Inc. (2006) Summary page 4.
- K143001: Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing, Argentum Medical (2014) Summary page 4.

## Indications for use
For professional use, Procellera Composite Antibacterial Wound Dressing is intended for the management of wounds to provide a moist wound environment and is indicated for partial and full-thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, first and second degree burns, surgical incisions, donor and recipient graft sites, etc. For over-the-counter use, Procellera Composite Antibacterial Wound Dressing is intended for the management of wounds to provide a moist wound environment and is indicated for superficial wounds such as minor cuts, scrapes, irritations, abrasions, blisters, etc.

Source page: https://510kreport.com/device/K180533
Methodology: https://510kreport.com/methodology