FRO
- Product code
- FRO
- Device name
- Dressing, Wound, Drug
- Device class
- Class U
- Medical specialty
- Unknown
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 707
510(k) clearances, last 3 years (58)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261646 | 2026-08-14 | Beijing Kreate Medical Co., Ltd. | Redermax® Antibacterial Wound Matrix | |
| K253665 | 2026-08-11 | Urgo Medical North America, LLC | Vashe Plus Antimicrobial Solution | |
| K261023 | 2026-06-24 | Sonoma Pharmaceuticals, Inc. | Microdacyn Wound Irrigation Solution | |
| K251929 | 2026-06-24 | Silverceuticals, Inc. | SilverCeuticals® Antimicrobial Wound Gel | |
| K261638 | 2026-06-17 | Oneness Biotech Co., Ltd. | Bonvadis® | |
| K254073 | 2026-05-13 | Merit Medical Systems, Inc. | StatSeal Disc | |
| K254191 | 2026-04-07 | InnovaCorium, Inc. | IWD-Gel | |
| K252023 | 2026-03-25 | Letus Corporation | MiraChlor Antimicrobial Wound Solution | |
| K251999 | 2026-03-13 | Solventum Germany GmbH | Promogran Prisma Collagen Matrix with ORC and Silve | |
| K252028 | 2026-03-11 | Huizhou Foryou Medical Co., Ltd. | LUOFUCON® Antimicrobial Wound Gel | |
| K251582 | 2026-02-02 | Beijing Kreate Medical Co., Ltd. | Redermax Antibacterial Wound Matrix | |
| K252568 | 2026-01-23 | Silk Holdings, Inc. | New Day Skin Spray | |
| K250890 | 2026-01-12 | Sioxmed, LLC | SBC1 Cream | |
| K252759 | 2026-01-08 | Kane Biotech, Inc. | revyve® Antimicrobial Skin and Wound Cleanser | |
| K251757 | 2026-01-05 | Innovacyn, Inc. | Puracyn® Plus Antimicrobial Irrigation Solution | |
| K252167 | 2025-12-19 | Qingdao Bright Moon Biomedical Materia | Enhanced Silver Gelling Fiber Dressing (OTC) Extra E | FDA |
| K250642 | 2025-11-19 | Huizhou Foryou Medical Devices Co., Lt | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Sque | |
| K250115 | 2025-10-14 | Rapid Nexus Nanotech Wound Solutions, | Hemastyl() Wound Dressing | |
| K251866 | 2025-10-10 | Solventum US, LLC | Tegaderm Post-Op Transparent Antimicrobial Dressing | |
| K243166 | 2025-08-27 | Infection Elimination Solutions, LLC | Dermalage | |
| K243415 | 2025-07-22 | P.G.F. Industry Solutions GmbH | Granudacyn® Wound Irrigation Solution | |
| K251093 | 2025-06-09 | Oneness Biotech Co., Ltd. | Bonvadis® | |
| K243457 | 2025-05-02 | Seriously Clean, Ltd. | Nixall Antimicrobial Solutions Skin & Wound Hydroge | |
| K243875 | 2025-04-21 | Spectrum Antimicrobials, Inc. | Spectricept Skin and Wound Cleanser | |
| K242406 | 2025-03-13 | Sioxmed, LLC | SiOxC Cream | FDA |
| K243001 | 2025-03-06 | Laboratorios Biogalenic S.A. DE C.V. | Sterile Water USP and Sterile 0.9% Normal Saline USP | |
| K240809 | 2024-12-16 | Huizhou Foryou Medical Devices Co., Lt | LUOFUCON® Silver Collagen Dressing | FDA |
| K242758 | 2024-12-09 | Hartmann USA, Inc. | Atrauman® Ag | |
| K242856 | 2024-11-13 | Huizhou Foryou Medical Devices Co., Lt | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription u | |
| K240510 | 2024-11-08 | Sonoma Pharmaceuticals, Inc. | Microdacyn Hydrogel | |
| K243181 | 2024-10-31 | Bionova Medical, Inc. | Foundation Dermal Regeneration Scaffold Plus (DRS+) | |
| K222740 | 2024-10-21 | Speciality Fibres and Materials, Ltd. | Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, | |
| K211943 | 2024-10-17 | Imbed Biosciences | Microlyte Ag/Lidocaine | |
| K240485 | 2024-10-07 | Huizhou Foryou Medical Devices Co., Lt | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus ( | |
| K240722 | 2024-09-20 | Raya Pharmaceuticals, LLC | Derma-R Cream (Derma-R Cream) | |
| K233399 | 2024-09-13 | Sonoma Pharmaceuticals, Inc. | Microdacyn Wound Care Solution | |
| K240298 | 2024-08-21 | Bionova Medical, Inc. | Foundation Dermal Regeneration Scaffold Plus (DRS+) | |
| K241225 | 2024-07-31 | Argentum Medical, LLC | Silverlon® Wound Contact, Burn Contact Dressing | |
| K241809 | 2024-07-19 | Kane Biotech, Inc. | coactiv+ Antimicrobial Wound Gel | |
| K212521 | 2024-07-18 | Kericure, Inc. | Field Shield Wound Dressing | |
| K240552 | 2024-06-18 | Irrimax Corporation | Irrisept Antimicrobial Wound Lavage | |
| K232333 | 2024-05-31 | Jinhua Jingdi Medical Supplies Co., Lt | Anti-bacterial bandage | |
| K232080 | 2024-05-31 | Innovacyn, Inc. | Puracyn® Plus Antimicrobial Irrigation Solution | |
| K233111 | 2024-05-24 | Foshan United Medical Technologies, Lt | ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Algina | |
| K232655 | 2024-05-22 | Stemcyte, Inc. | Bonvadis® | |
| K223360 | 2024-03-27 | Huizhou Foryou Medical Devices Co., Lt | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Sili | |
| K233151 | 2024-03-26 | Medline Industries, LP | PluroGel® Antimicrobial Burn and Wound Dressing, Plu | |
| K231953 | 2024-03-22 | Coloplast Corp. | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in) | |
| K231088 | 2024-01-11 | Roosin Medical Co., Ltd. | Copper Foam Dressing (Prescription and OTC) | |
| K221110 | 2024-01-04 | Huizhou Foryou Medical Devices Co., Lt | LUOFUCON Silver Gelling Fiber Surgical Dressing, LUO | |
| K223359 | 2023-12-21 | Huizhou Foryou Medical Devices Co., Lt | LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacte | FDA |
| K231057 | 2023-12-01 | Winner Medical Co., Ltd. | Antibacterial Gel Wound Dressing | |
| K230190 | 2023-11-17 | Roosin Medical Co., Ltd. | Polyver Silver Alginate Dressing (Prescription and O | |
| K231564 | 2023-11-10 | Winner Medical Co., Ltd. | Skin and Wound Cleanser | |
| K213473 | 2023-10-26 | Advanced Medical Solutions, Ltd. | Antimicrobial Gelling Fiber Dressing with PHMB | |
| K222143 | 2023-10-13 | Sweetbio, Inc. | APIS (R), VERIS (TM) | FDA |
| K222025 | 2023-10-11 | Gel4med, Inc. | G4Derm / G4Derm Plus Synthetic Wound Matrix | |
| K221570 | 2023-09-29 | Allmed Medical Products Co., Ltd. | Antibacterial bandage |
Official FDA classification page: FRO
Classification and pathway per current FDA publications. Data from openFDA (CC0).