# K141637: SPB Skin Emulsion

- Pathway: 510(k) (Traditional)
- Applicant: Biotd S.A.
- Decided: Jun 3, 2015 after 349 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.

## Indications for use
As a prescription topical skin care emulsion to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. SPB helps maintain a moist wound & skin environment, which is beneficial to the healing process. An OTC topical skin care emulsion to relieve the burning and itching associated with many common types of skin irritation. SPB helps maintain a moist wound & skin environment, which is beneficial to the healing process.

Source page: https://510kreport.com/device/K141637
Methodology: https://510kreport.com/methodology