# K132329: Nivatopic Plus

- Pathway: 510(k) (Traditional)
- Applicant: Nivagen Pharmaceuticals, Inc.
- Decided: Dec 20, 2013 after 147 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: 7 generations back to K961758 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110727: Hylatopicplus Cream, Precision Dermatology Incorporated (2011) Summary page 1.
- K113774: HPR Plus Emollient Foam, Prugen IP Holdings, Inc. (2012) Summary page 2.

## Indications for use
Rx: NivatopicTM Plus is indicated to manage and relieve the burning, itching, and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. NivatopicTM Plus also helps relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Source page: https://510kreport.com/device/K132329
Methodology: https://510kreport.com/methodology