Cleared Traditional

K120181 - LUFUCON SILVER ALGINATE DRESSING 50X50MM

K120181 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery device
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Feb 2013
Decision
391d
Days
-
Risk

K120181 is an FDA 510(k) clearance for the LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 10.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Pennington, US). The FDA issued a Cleared decision on February 14, 2013 after a review of 391 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 K120181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2012
Decision Date February 14, 2013
Days to Decision 391 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
276d slower than avg
Panel avg: 115d · This submission: 391d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 212
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K120181.
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
K161623 · B.Braun Medical, Inc. · Nov 2016
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CURAD ANTIBACTERIAL BANDAGE
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BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
K120828 · Coloplast A/S · Apr 2012
3M TEGADERM MATRIX DRESSING
K110457 · 3M Company · Dec 2011