Cleared Traditional

K112549 - IV CLEAR ANTIMICROBIAL CLEAR SILICONE A...

K112549 · Covalontechnologies, Inc. · General & Plastic Surgery device
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May 2012
Decision
246d
Days
-
Risk

K112549 is an FDA 510(k) clearance for the IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AN.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Covalontechnologies, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on May 4, 2012 after a review of 246 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 Covalontechnologies, Inc. devices

FDA 510(k) Submission Details - K112549

510(k) Number K112549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2011
Decision Date May 04, 2012
Days to Decision 246 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
131d slower than avg
Panel avg: 115d · This submission: 246d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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