# K070309: Neosalus

- Pathway: 510(k) (Traditional)
- Applicant: Quinnova Pharmaceuticals
- Decided: Sep 12, 2008 after 589 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.
5 later devices descend from it; 1 cites it directly.
0 of 10 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 1.
- K964240: Biafine Wound Dressing Emulsion, Medix Pharmaceuticals Americas, Inc. (1997) Summary page 1.

## Most influential descendants
- K090585: Neosalus Cream (2009), 4 descendants of its own
- K240722: Derma-R Cream (Derma-R Cream) (2024), 0 descendants of its own
- K170911: NEOCERA Advanced Barrier Cream (2017), 0 descendants of its own
- K113807: Dexeryl Cream (2012), 0 descendants of its own
- K091719: Neosalus Lotion (2009), 0 descendants of its own

## Indications for use
Neosalus is indicated for management and relief of irritation associated with various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.

Source page: https://510kreport.com/device/K070309
Methodology: https://510kreport.com/methodology