# K243457: Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel

- Pathway: 510(k) (Traditional)
- Applicant: Seriously Clean, Ltd.
- Decided: May 2, 2025 after 176 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
The Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is intended to be used for Over-The-Counter and Prescription Use. The Over-The-Counter use is intended for the following indications: • For use on minor skin irritations, minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns. • To moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement. The Prescription Use Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is indicated for the following uses: • Use with dermal irritation, sores, injuries and ulcers of dermal tissues. • Moistening and lubricating absorbent wound dressings and the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. • Management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I – IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.

Source page: https://510kreport.com/device/K243457
Methodology: https://510kreport.com/methodology