Cleared Traditional

BIOPAD (K040283) - FDA 510(k) Clearance

K040283 · Euroresearch Srl · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
532d
Days
-
Risk

K040283 is an FDA 510(k) clearance for the BIOPAD. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Euroresearch Srl (Crofton, US). The FDA issued a Cleared decision on July 22, 2005 after a review of 532 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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Submission Details

510(k) Number K040283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2004
Decision Date July 22, 2005
Days to Decision 532 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
417d slower than avg
Panel avg: 115d · This submission: 532d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.