Cleared Traditional

K120181 - LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM

K120181 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K120181

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
PCCP Authorized No
Regulatory Context
Review time vs. panel average
276d slower than avg
Panel avg: 115d · This submission: 391d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 457
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