Cleared Traditional

K103106 - CHLORASHIELD TM ANTIMICROBIAL DRESSING

K103106 · Care Fusion 213, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
161d
Days
-
Risk

K103106 is an FDA 510(k) clearance for the CHLORASHIELD TM ANTIMICROBIAL DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Care Fusion 213, LLC (Leawood, US). The FDA issued a Cleared decision on March 30, 2011 after a review of 161 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 Care Fusion 213, LLC devices

FDA 510(k) Submission Details - K103106

510(k) Number K103106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2010
Decision Date March 30, 2011
Days to Decision 161 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
46d slower than avg
Panel avg: 115d · This submission: 161d
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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