Cleared Traditional

K070685 - KENDALL ANTIMICROBIAL DRAIN DRESSING FO...

K070685 · Tyco Healthcare · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Sep 2007
Decision
186d
Days
-
Risk

K070685 is an FDA 510(k) clearance for the KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on September 14, 2007 after a review of 186 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 Tyco Healthcare devices

Submission Details

510(k) Number K070685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2007
Decision Date September 14, 2007
Days to Decision 186 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
71d slower than avg
Panel avg: 115d · This submission: 186d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 212
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K070685.
PRONTOSAN WOUND IRRIGATION SOLUTION
K072876 · B.Braun Medical, Inc. · Jun 2008
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
K071552 · Medline Industries, Inc. · Apr 2008
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
K072378 · Arthrex, Inc. · Nov 2007
ALLEVYN AG DRESSING
K063835 · Smith & Nephew, Inc. · Aug 2007
3M TEGADERM CHG DRESSING
K063458 · 3M Company · Apr 2007
3M TEGADERM SILVER (AG) MESH
K053256 · 3M Company · Dec 2005