# K052643: Epiceram

- Pathway: 510(k) (Traditional)
- Applicant: Ceragenix Corporation
- Decided: Apr 11, 2006 after 197 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: 3 generations back to K961758 (1996). 4 ancestors in all.
16 later devices descend from it; 9 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024367: Sinclair Wound and Skin Emulsion, Sinclair Pharmaceuticals, Ltd. (2003) Summary page 1.
- K964240: Biafine Wound Dressing Emulsion, Medix Pharmaceuticals Americas, Inc. (1997) Summary page 1.
- K961758: Carasyn Hydrogel Wound Products, Carrington Laboratories, Inc. (1996) Summary page 1.
- K041342: Impruv a.I. Cream Wound and Skin Emulsion, Stiefel Laboratories, Inc. (2005) Summary page 1.

## Most influential descendants
- K093051: Hylatopic Plus Emollient Foam (2009), 6 descendants of its own
- K110727: Hylatopicplus Cream (2011), 4 descendants of its own
- K242406: SiOxC Cream (2025), 1 descendant of its own
- K113774: HPR Plus Emollient Foam (2012), 1 descendant of its own
- K110757: TL-Cermide Skin Barrier Emulsion (2011), 1 descendant of its own

## Indications for use
EPICERAM® is a skin barrier emulsion to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, radiation dermatitis. EPICERAM® helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Apply Epiceram® in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin. If the skin is broken, cover Epiceram® with a dressing of choice.

Source page: https://510kreport.com/device/K052643
Methodology: https://510kreport.com/methodology