# K252759: revyve® Antimicrobial Skin and Wound Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Kane Biotech, Inc.
- Decided: Jan 8, 2026 after 132 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: 11 generations back to K914579 (1992). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160192: Atteris Antimicrobial Skin & Wound Cleanser, Rochal Industries, LLC (2016) Summary page 5.
- K141660: Nawalution Skin and Wound Cleanser, Nawa Heilmittel GmbH (2014) Summary page 5.

## Indications for use
Rx use: revyve® Antimicrobial Skin and Wound Cleanser for prescription use is intended for use under the supervision of healthcare professionals for mechanical cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I - IV pressure ulcers, venous ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and superficial second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions. OTC use: revyve® Antimicrobial Skin and Wound Cleanser for OTC use is intended for mechanical cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations, and minor burns.

Source page: https://510kreport.com/device/K252759
Methodology: https://510kreport.com/methodology