Cleared Traditional

K003229 - BIOPATCH ANTIMICROBIAL DRESSING (FDA 510(k) Clearance)

K003229 · Integra Lifesciences Corp. · General & Plastic Surgery device
Oct 2001
Decision
381d
Days
-
Risk

K003229 is an FDA 510(k) clearance for the BIOPATCH ANTIMICROBIAL DRESSING. Classified as Securement Wound Dressing For Reduction Of Infection (product code SEL).

Submitted by Integra Lifesciences Corp. (Somerville, US). The FDA issued a Cleared decision on October 26, 2001 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

Submission Details

510(k) Number K003229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2000
Decision Date October 26, 2001
Days to Decision 381 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
249d slower than avg
Panel avg: 132d · This submission: 381d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SEL Securement Wound Dressing For Reduction Of Infection
Device Class -
Definition These Dressings Are Intended To Be Placed Over A Vascular Or Percutaneous Device (e.g., Needle, Catheter, Drain) To Keep It Securely Anchored To The Skin, Cover And Protect The Insertion Site, And May Additionally Absorb Exudate. When Used To Secure Central Venous Or Arterial Catheters, A Securement Wound Dressing For Reduction Of Infection Is Intended To Reduce Microbial Colonization Around The Insertion Site And Reduce The Incidence Of Catheter-related Bloodstream Infections (crbsi).