Cleared Traditional

K140954 - LUOFUCON SILVER PU ANTIBACTERIAL FOAM D...

K140954 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery device
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Mar 2015
Decision
343d
Days
-
Risk

K140954 is an FDA 510(k) clearance for the LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 23, 2015 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Huizhou Foryou Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K140954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2014
Decision Date March 23, 2015
Days to Decision 343 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
228d slower than avg
Panel avg: 115d · This submission: 343d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 212
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