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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 the device name listed in this FDA 510(k) record. The listed applicant is Kane Biotech, Inc.. It received FDA 510(k) clearance on 2026-01-08 under 510(k) 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. The listed applicant is Kane Biotech, Inc.. The 510(k) number is K252759.

When did revyve® Antimicrobial Skin and Wound Cleanser receive FDA 510(k) clearance?

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

Who is the listed applicant for revyve® Antimicrobial Skin and Wound Cleanser?

The FDA 510(k) record lists Kane Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06011603Prineo Sensitivity Dressing StudyCOMPLETEDNCT07099482"Ultrasound-Enhanced Propolis Therapy for Healing Diabetic Foot Wounds"NOT_YET_RECRUITING

Other records listing Kane Biotech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241809coactiv+™ Antimicrobial Wound GelK223259coactiv+™ Antimicrobial Wound Gel

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

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.

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