Cleared Traditional

K140147 - BCT ANTIMICROBIAL DRESSING & BCT SILVER...

K140147 · Bio-Medical Carbon Technology Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 2014
Decision
90d
Days
-
Risk

K140147 is an FDA 510(k) clearance for the BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Bio-Medical Carbon Technology Co., Ltd. (Austin, US). The FDA issued a Cleared decision on April 22, 2014 after a review of 90 days - within the typical 510(k) review window.

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 Bio-Medical Carbon Technology Co., Ltd. devices

FDA 510(k) Submission Details - K140147

510(k) Number K140147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2014
Decision Date April 22, 2014
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 237
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