FRO

FDA Product Code FRO: Dressing, Wound, Drug

FDA product code FRO covers drug-eluting wound dressings that combine a wound contact layer with an active pharmaceutical ingredient.

These dressings deliver antimicrobial agents, growth factors, or analgesics directly to the wound bed while maintaining a moist healing environment. The drug component provides local therapeutic activity beyond the mechanical protection of a standard dressing.

FRO devices are reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Huizhou Foryou Medical Devices Co., Ltd., Convatec, A Division of E.R. Squibb & Sons and Derma Sciences, Inc..

707
Total
707
Cleared
187d
Avg days
1978
Since
Stable submission activity - 34 submissions in the last 2 years
Review times increasing: avg 234d recently vs 185d historically

FDA 510(k) Cleared Dressing, Wound, Drug Devices (Product Code FRO)

707 devices
1–24 of 707
Cleared Aug 14, 2026
Redermax® Antibacterial Wound Matrix
K261646
Beijing Kreate Medical Co., Ltd.
General & Plastic Surgery · 88d
Cleared Aug 11, 2026
Vashe Plus Antimicrobial Solution
K253665
Urgo Medical North America, LLC
General & Plastic Surgery · 263d
Cleared Jun 24, 2026
SilverCeuticals® Antimicrobial Wound Gel
K251929
Silverceuticals, Inc.
General & Plastic Surgery · 366d
Cleared Jun 24, 2026
Microdacyn Wound Irrigation Solution
K261023
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 86d
Cleared Jun 17, 2026
Bonvadis®
K261638
Oneness Biotech Co., Ltd.
General & Plastic Surgery · 30d
Cleared May 13, 2026
StatSeal Disc
K254073
Merit Medical Systems, Inc.
General & Plastic Surgery · 146d
Cleared Apr 07, 2026
IWD-Gel™
K254191
InnovaCorium, Inc.
General & Plastic Surgery · 105d
Cleared Mar 25, 2026
MiraChlor Antimicrobial Wound Solution
K252023
Letus Corporation
General & Plastic Surgery · 268d
Cleared Mar 13, 2026
Promogran Prisma™ Collagen Matrix with ORC and Silver
K251999
Solventum Germany GmbH
General & Plastic Surgery · 259d
Cleared Mar 11, 2026
LUOFUCON® Antimicrobial Wound Gel
K252028
Huizhou Foryou Medical Co., Ltd.
General & Plastic Surgery · 254d
Cleared Feb 02, 2026
Redermax Antibacterial Wound Matrix
K251582
Beijing Kreate Medical Co., Ltd.
General & Plastic Surgery · 255d
Cleared Jan 23, 2026
New Day Skin Spray
K252568
Silk Holdings, Inc.
General & Plastic Surgery · 162d
Cleared Jan 12, 2026
SBC1 Cream
K250890
Sioxmed, LLC
General & Plastic Surgery · 293d
Cleared Jan 08, 2026
revyve® Antimicrobial Skin and Wound Cleanser
K252759
Kane Biotech, Inc.
General & Plastic Surgery · 132d
Cleared Jan 05, 2026
Puracyn® Plus Antimicrobial Irrigation Solution
K251757
Innovacyn, Inc.
General & Plastic Surgery · 210d
Cleared Dec 19, 2025
Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)
K252167
Qingdao Bright Moon Biomedical Materials Co., Ltd.
General & Plastic Surgery · 162d
Cleared Nov 19, 2025
LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
K250642
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 260d
Cleared Oct 14, 2025
Hemastyl(™) Wound Dressing
K250115
Rapid Nexus Nanotech Wound Solutions, Inc.
General & Plastic Surgery · 271d
Cleared Oct 10, 2025
Tegaderm Post-Op Transparent Antimicrobial Dressing
K251866
Solventum US, LLC
General & Plastic Surgery · 115d
Cleared Aug 27, 2025
Dermalage
K243166
Infection Elimination Solutions, LLC
General & Plastic Surgery · 331d
Cleared Jul 22, 2025
Granudacyn® Wound Irrigation Solution
K243415
P.G.F. Industry Solutions GmbH
General & Plastic Surgery · 263d
Cleared Jun 09, 2025
Bonvadis®
K251093
Oneness Biotech Co., Ltd.
General & Plastic Surgery · 60d
Cleared May 02, 2025
Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel
K243457
Seriously Clean, Ltd.
General & Plastic Surgery · 176d
Cleared Apr 21, 2025
Spectricept Skin and Wound Cleanser
K243875
Spectrum Antimicrobials, Inc.
General & Plastic Surgery · 125d

About Product Code FRO - Regulatory Context

510(k) Submission Activity

707 total 510(k) submissions under product code FRO since 1978, with 707 receiving FDA clearance (average review time: 187 days).

Submission volume has remained relatively stable over the observed period, with 34 submissions in the last 24 months.

FDA 510(k) Review Time - FRO Product Code

Recent submissions under FRO have taken an average of 234 days to reach a decision - up from 185 days historically. Manufacturers should account for longer review timelines in current project planning.

FRO devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →