Cleared Traditional

K042352 - BIODERM SCIENCES WOUND CREAM

K042352 · Bioderm Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
413d
Days
-
Risk

K042352 is an FDA 510(k) clearance for the BIODERM SCIENCES WOUND CREAM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Bioderm Sciences, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on October 17, 2005 after a review of 413 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.

FDA 510(k) Submission Details - K042352

510(k) Number K042352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2004
Decision Date October 17, 2005
Days to Decision 413 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
298d slower than avg
Panel avg: 115d · This submission: 413d
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 700
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K042352 · BIODERM SCIENCES WOUND CREAM
Download PDF FDA Summary Bioderm Sciences, Inc.