K251582 is an FDA 510(k) clearance for the Redermax Antibacterial Wound Matrix. This device is classified as a Dressing, Wound, Drug.
Submitted by Beijing Kreate Medical Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on February 2, 2026, 255 days after receiving the submission on May 23, 2025.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K251582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2025 |
| Decision Date | February 02, 2026 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |