# K254041: SkinSmart Antimicrobial HydroGel

- Pathway: 510(k) (Traditional)
- Applicant: Magic Science Supply, LLC
- Decided: Sep 11, 2026 after 269 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: 9 generations back to K914579 (1992). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150799: Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel,  Puracyn (R) Plus Antimicrobial Hydrogel Professional Formula, Innovacyn, Inc. (2015) Summary page 5.

## Indications for use
For Over-the-Counter Use: For the Management of minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns. Prescription Use: For use by healthcare professionals or as directed to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. For management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot, leg ulcers, post-surgical wounds, first-and superficial second-degree burns, surgical wounds (donor and graft sites, incisions), trauma wounds, in addition to moistening and lubricating absorbent wound dressings.

Source page: https://510kreport.com/device/K254041
Methodology: https://510kreport.com/methodology