# K152533: Xonrid Gel

- Pathway: 510(k) (Traditional)
- Applicant: Helsinn Healthcare SA
- Decided: Oct 28, 2016 after 421 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.
No later device cites it as a predicate yet.
0 of 5 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 4.
- K024367: Sinclair Wound and Skin Emulsion, Sinclair Pharmaceuticals, Ltd. (2003) Summary page 4.

## Indications for use
Under the supervision of a healthcare professional, Xonrid® Gel is indicated to manage and relieve the burning and itching experienced with radiation dermatitis. Xonrid® Gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. Not intended to be used on open wounds.

Source page: https://510kreport.com/device/K152533
Methodology: https://510kreport.com/methodology