# K113772: HPR Emollient Foam

- Pathway: 510(k) (Traditional)
- Applicant: Prugen IP Holdings, Inc.
- Decided: Feb 9, 2012 after 49 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)
- K083024: Hylatopic Emollient Foam, Collegium Pharmaceutical Incorporated (2009) Summary page 1.

## Indications for use
HPRTM Emollient Foam is indicated to manage and relieve the burning, itching and pain associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis. HPRTM Emollient Foam also 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/K113772
Methodology: https://510kreport.com/methodology