Recent FDA 510(k) Clearances: Antimicrobial Linens and Healthcare Devices
22 antimicrobial medical devices cleared by the FDA since 2023, including antimicrobial linens, wound dressings and healthcare textiles. Data sourced from the FDA 510(k) public files. Updated monthly.
About antimicrobial linens and healthcare device clearances
This page tracks recent FDA 510(k) clearances for antimicrobial medical devices used in healthcare settings, including antimicrobial linens, wound dressings, wound irrigation solutions, skin cleansers and surgical drapes. These devices incorporate antimicrobial agents such as chlorhexidine gluconate (CHG), silver compounds, PHMB (polyhexamethylene biguanide) or hypochlorous acid to reduce infection risk in clinical environments.
Antimicrobial linens and healthcare textiles cleared via FDA 510(k) are regulated primarily under the General & Plastic Surgery FDA review panel, with product codes FRO (wound dressings and solutions) and FQH (antimicrobial irrigation systems). All clearances use the Traditional 510(k) pathway via substantial equivalence (SESE).
Average FDA review time for this segment over the last four years: 191 days. At 191 days, antimicrobial healthcare devices take significantly longer than the FDA's standard 90-day review target, reflecting the unclassified regulatory status of many antimicrobial wound products.
Recent 510(k) Clearances: Antimicrobial Healthcare Devices 2026 6 devices
| 510(k) | Device | Manufacturer | Decision | Code | Days |
|---|---|---|---|---|---|
| K252023 | MiraChlor Antimicrobial Wound Solution | Letus Corporation | Cleared | FRO | 268d |
| K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | Cleared | FRO | 254d |
| K253996 | BD Surgiphor™ Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | Cleared | FQH | 75d |
| K253445 | BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) | Bd | Cleared | FQH | 141d |
| K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | Cleared | FRO | 132d |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | Cleared | FRO | 210d |
Recent 510(k) Clearances: Antimicrobial Healthcare Devices 2025 3 devices
| 510(k) | Device | Manufacturer | Decision | Code | Days |
|---|---|---|---|---|---|
| K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | Cleared | EBF | 1d |
| K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC | Cleared | FRO | 115d |
| K243457 | Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel | Seriously Clean, Ltd. | Cleared | FRO | 176d |
Recent 510(k) Clearances: Antimicrobial Healthcare Devices 2024 5 devices
| 510(k) | Device | Manufacturer | Decision | Code | Days |
|---|---|---|---|---|---|
| K240485 | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) | Huizhou Foryou Medical Devices Co., Ltd. | Cleared | FRO | 230d |
| K241809 | coactiv+™ Antimicrobial Wound Gel | Kane Biotech, Inc. | Cleared | FRO | 28d |
| K240552 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | Cleared | FRO | 111d |
| K232080 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | Cleared | FRO | 323d |
| K233151 | PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) | Medline Industries, LP | Cleared | FRO | 181d |
Recent 510(k) Clearances: Antimicrobial Healthcare Devices 2023 6 devices
| 510(k) | Device | Manufacturer | Decision | Code | Days |
|---|---|---|---|---|---|
| K213473 | Antimicrobial Gelling Fiber Dressing with PHMB | Advanced Medical Solutions, Ltd. | Cleared | FRO | 728d |
| K230645 | BeneHold™ Surgical Incise Drape with CHG antimicrobial II | Avery Dennison Medical , Ltd. | Cleared | KKX | 231d |
| K223526 | ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing | Smith & Nephew Medical Limited | Cleared | FRO | 268d |
| K223259 | coactiv+™ Antimicrobial Wound Gel | Kane Biotech, Inc. | Cleared | FRO | 212d |
| K223310 | Antimicrobial Silicone PHMB Foam Wound Dressing | Advanced Medical Solutions Limited | Cleared | FRO | 159d |
| K221755 | Antimicrobial gauze sponge dressing | Winner Medical Co., Ltd. | Cleared | FRO | 211d |
Recent 510(k) Clearances: Antimicrobial Healthcare Devices 2022 2 devices
| 510(k) | Device | Manufacturer | Decision | Code | Days |
|---|---|---|---|---|---|
| K221504 | BD Surgiphor™ Antimicrobial Irrigation System | Bd | Cleared | FQH | 144d |
| K222804 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | Cleared | FQH | 6d |
FDA regulatory context for antimicrobial linens and healthcare devices
Classification note: Wound dressings, antimicrobial linens and liquid wound washes containing antimicrobials are regulated as unclassified pre-amendments devices requiring 510(k) clearance. The FDA proposed reclassification of certain antimicrobial wound products in 2024. Devices cleared prior to any reclassification rule retain their existing clearance status.
Source: FDA 510(k) public files. 175,730 total devices indexed. Updated monthly.
Data source
All clearance data sourced from FDA 510(k) downloadable files (public domain, 17 U.S.C. § 105). Filtered to devices with "antimicrobial" in the FDA-registered device name. Dataset published on Zenodo (DOI: 10.5281/zenodo.20269611).