Cleared Traditional

K113583 - CURAD ANTIBACTERIAL BANDAGE

K113583 · Medline Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
129d
Days
-
Risk

K113583 is an FDA 510(k) clearance for the CURAD ANTIBACTERIAL BANDAGE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on April 12, 2012 after a review of 129 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.

FDA 510(k) Submission Details - K113583

510(k) Number K113583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2011
Decision Date April 12, 2012
Days to Decision 129 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 115d · This submission: 129d
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 674
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K113583.
MANUKA FILL
K121227 · Links Medical Products, Inc. · May 2012
IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
K112549 · Covalontechnologies, Inc. · May 2012
SALINE WOUND WASH
K112666 · Nanoplas, Inc. · Apr 2012
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
K120828 · Coloplast A/S · Apr 2012
DEXERYL CREAM
K113807 · Pierre Fabre Medical Devices · Mar 2012
HPR EMOLLIENT FOAM
K113772 · Prugen IP Holdings, Inc. · Feb 2012
K113583 · CURAD ANTIBACTERIAL BANDAGE
Download PDF Medline Industries, I…