# K102945: Pediacyn Atopic Dermatitis Hydrogel

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Innovative Sciences, Inc.
- Decided: Feb 2, 2011 after 121 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 K830708 (1983). 15 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090092: Sockit! and Mcmerlin Dermal Wound Gel, Mcmerlin Dental Products LP (2009) Summary page 1.
- K093585: Microcyn Skin and Wound Hydrogel, Oculus Innovative Sciences, Inc. (2010) Summary page 1.
- K024367: Sinclair Wound and Skin Emulsion, Sinclair Pharmaceuticals, Ltd. (2003) Summary page 3.

## Most influential descendants
- K123071: Vashe Skin and Wound Hydrogel (2013), 11 descendants of its own
- K141863: Puricore Wound Hydrogel Spray Dressing (2015), 10 descendants of its own
- K150799: Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel,  Puracyn (R) Plus Antimicrobial Hydrogel Professional Formula (2015), 9 descendants of its own
- K143590: Alevicyn SG Antipruritic Gel (2015), 4 descendants of its own
- K160095: Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz (2016), 3 descendants of its own

## Indications for use
Under the supervision of a health care professional, Epicyn HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis. Epicyn HydroGel may be also used to relieve the pain of first and second degree burns. Epicyn HydroGel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Source page: https://510kreport.com/device/K102945
Methodology: https://510kreport.com/methodology