# K252568: New Day Skin Spray

- Pathway: 510(k) (Traditional)
- Applicant: Silk Holdings, Inc.
- Decided: Jan 23, 2026 after 162 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: 4 generations back to K961758 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052643: Epiceram, Ceragenix Corporation (2006) Summary page 5.

## Indications for use
New Day Skin Spray is a skin emulsion indicated for the management of dryness of skin, and atopic dermatitis. New Day Skin Spray maintains a moist skin and wound environment beneficial to the healing process.

Source page: https://510kreport.com/device/K252568
Methodology: https://510kreport.com/methodology