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..

710
Total
710
Cleared
188d
Avg days
1978
Since
Declining activity - 32 submissions in the last 2 years vs 41 in the prior period
Consistent review times: 196d avg (recent)

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

710 devices
1–24 of 710
Cleared Oct 26, 2026
Triad Hydrophilic Wound Dresssing (1964, 2.5 oz)
K260285
Coloplast Corp.
General & Plastic Surgery · 270d
Cleared Sep 22, 2026
Actolind® (06.3637. Actolind® Gel Plus)
K254168
ACTO GmbH
General & Plastic Surgery · 273d
Cleared Sep 11, 2026
SkinSmart Antimicrobial HydroGel
K254041
Magic Science Supply, LLC
General & Plastic Surgery · 269d
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

About Product Code FRO - Regulatory Context

510(k) Submission Activity

710 total 510(k) submissions under product code FRO since 1978, with 710 receiving FDA clearance (average review time: 188 days).

Submission volume has declined in recent years - 32 submissions in the last 24 months compared to 41 in the prior period.

FDA 510(k) Review Time - FRO Product Code

FDA review times for FRO submissions have been consistent, averaging 196 days recently vs 187 days historically.

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