Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

revyve® Antimicrobial Skin and Wound Cleanser

K-Number: K252759 · 2026-01-08

ApplicantKane Biotech, Inc.
Decision Date2026-01-08
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

revyve® Antimicrobial Skin and Wound Cleanser is a medical device manufactured by Kane Biotech, Inc.. It received FDA 510(k) clearance on 2026-01-08 under approval number K252759. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the revyve® Antimicrobial Skin and Wound Cleanser?

revyve® Antimicrobial Skin and Wound Cleanser is a medical device that received FDA 510(k) clearance on 2026-01-08. It is manufactured by Kane Biotech, Inc.. The 510(k) number is K252759.

When was revyve® Antimicrobial Skin and Wound Cleanser approved by the FDA?

revyve® Antimicrobial Skin and Wound Cleanser received FDA 510(k) clearance on 2026-01-08, under approval number K252759.

What company makes revyve® Antimicrobial Skin and Wound Cleanser?

revyve® Antimicrobial Skin and Wound Cleanser is manufactured by Kane Biotech, Inc..

What is the FDA product code for revyve® Antimicrobial Skin and Wound Cleanser?

The FDA product code for revyve® Antimicrobial Skin and Wound Cleanser is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

NCT07604636 Adjunctive Ozone Therapy for Residual Periodontal Pockets COMPLETED NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING NCT07099482 "Ultrasound-Enhanced Propolis Therapy for Healing Diabetic Foot Wounds" NOT_YET_RECRUITING NCT07551297 Ozone Therapy After Open Flap Debridement in Periodontitis COMPLETED NCT07066254 The Mepilex Cesarean Delivery Trial NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025)

Other Devices by Kane Biotech, Inc.

K223259coactiv+™ Antimicrobial Wound Gel K241809coactiv+™ Antimicrobial Wound Gel

Related Devices (Code: FRO)

K160695Talymed SuspensionMarine Polymer Technologies, Inc. K160872PolyPlex Wound DressingGlobal Health Solutions, LLC K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc. K152533Xonrid GelHelsinn Healthcare SA K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation K161212Atteris Antimicrobial Skin ProtectantRochal Industries, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑