# K140905: Dermafine

- Pathway: 510(k) (Traditional)
- Applicant: Invado Pharmaceuticals
- Decided: May 8, 2015 after 394 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: 5 generations back to K961758 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110172: Sonafine Wound Dressing, Stratus Pharmaceutical (2011) Summary page 4.
- K041342: Impruv a.I. Cream Wound and Skin Emulsion, Stiefel Laboratories, Inc. (2005) Summary page 4.
- K082089: Prumyx Cream, Prugen, Inc. (2009) Summary page 4.

## Indications for use
Rx Indications for Use: DermaFINE 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 by maintaining a moist wound and skin environment. OTC Indications for Use: DermaFINE Wound Dressing Emulsion is indicated for the management of minor cuts, minor burns, and minor lacerations by maintaining a moist wound and skin environment.

Source page: https://510kreport.com/device/K140905
Methodology: https://510kreport.com/methodology