Redermax Antibacterial Wound Matrix— 510(k) K251582
Substantially EquivalentBeijing Kreate Medical Co., Ltd.
FDA 510(k) clearance K251582 for Redermax Antibacterial Wound Matrix, Substantially Equivalent on 2026-02-02. Applicant: Beijing Kreate Medical Co., Ltd.. Device class: Unclassified.
Summary
Beijing Kreate Medical's Redermax Antibacterial Wound Matrix is filed under product code FRO, drug wound dressing. The record doesn't describe the matrix beyond its name and that code name.
Class U, with no regulation number. The classification panel is listed as Unknown, and the General, Plastic Surgery review panel handled it as a Traditional 510(k).
Beijing Kreate Medical filed from Beijing, China. FDA found it substantially equivalent 255 calendar days after receipt (May 23, 2025 to February 2, 2026).
Clearance details
- Applicant
- Beijing Kreate Medical Co., Ltd.
- Product code
- Product code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Recent devices under product code FRO
view allMore clearances from Beijing Kreate Medical Co., Ltd.
view allAdverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.