# K130350: Procellera

- Pathway: 510(k) (Traditional)
- Applicant: Vomaris Innovations, Inc.
- Decided: Jul 2, 2013 after 140 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). 8 ancestors in all.
2 later devices descend from it; 2 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)
- K081977: Prosit Wound Treatment Device, Silverleaf Medical Products, Inc. (2008) Summary page 2.
- K060237: CMB Antimicrobial Dressing, Silverleaf Medical Products, Inc. (2006) Summary page 1.

## Most influential descendants
- K160783: Procellera (2016), 1 descendant of its own
- K180533: Procellera Composite Antibacterial Wound Dressing (2018), 0 descendants of its own

## Indications for use
For prescription use, Procellera® antimicrobial 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/or recipient graft sites, etc. For over-the-counter use, Procellera® 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/K130350
Methodology: https://510kreport.com/methodology