Cleared Traditional

Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) (K252167) - FDA 510(k) Clearance

K252167 · Qingdao Bright Moon Biomedical Materials Co., Ltd. · General & Plastic Surgery device
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Dec 2025
Decision
162d
Days
-
Risk

K252167 is an FDA 510(k) clearance for the Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fi.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Qingdao Bright Moon Biomedical Materials Co., Ltd. (Qingdao, CN). The FDA issued a Cleared decision on December 19, 2025 after a review of 162 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Qingdao Bright Moon Biomedical Materials Co., Ltd. devices

Submission Details

510(k) Number K252167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2025
Decision Date December 19, 2025
Days to Decision 162 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 115d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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