# K250890: SBC1 Cream

- Pathway: 510(k) (Traditional)
- Applicant: Sioxmed, LLC
- Decided: Jan 12, 2026 after 293 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)
- K242406: SiOxC Cream, Sioxmed, LLC (2025) Summary page 5.

## Indications for use
The SBC1 Cream is a skin emulsion indicated for management of pruritus and dryness of skin in atopic dermatitis and allergic contact dermatitis. Not to be used on breached or compromised skin or open sores.

Source page: https://510kreport.com/device/K250890
Methodology: https://510kreport.com/methodology