# K110172: Sonafine Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Stratus Pharmaceutical
- Decided: Aug 19, 2011 after 211 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 K961758 (1996). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041342: Impruv a.I. Cream Wound and Skin Emulsion, Stiefel Laboratories, Inc. (2005) Summary page 1.
- K964240: Biafine Wound Dressing Emulsion, Medix Pharmaceuticals Americas, Inc. (1997) Summary page 1.
- K082089: Prumyx Cream, Prugen, Inc. (2009) Summary page 1.

## Most influential descendants
- K233151: PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) (2024), 0 descendants of its own
- K140905: Dermafine (2015), 0 descendants of its own

## Indications for use
SONAFINE® Wound Dressing is indicated for topical use in the management of full and partial thickness wounds including dermal ulcers, leg ulcers, superficial wounds, first and second degree burns and donor sites to include: Radiation Dermatitis Various types of dermatoses Atopic dermatitis Allergic contact dermatitis Dry waxy skin SONAFINE® Wound Dressing maintains a moist wound and skin environment. SONAFINE® Wound Dressing is indicated for the management of minor cuts, minor burns, and minor lacerations. SONAFINE® Wound Dressing maintains a moist wound and skin environment.

Source page: https://510kreport.com/device/K110172
Methodology: https://510kreport.com/methodology