Cleared Traditional

BIODERM MEDICAL COMPOSITE WOUND DRESSING (K946292) - FDA 510(k) Clearance

K946292 · Bioderm, Inc. · General & Plastic Surgery device
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Feb 1995
Decision
41d
Days
-
Risk

K946292 is an FDA 510(k) clearance for the BIODERM MEDICAL COMPOSITE WOUND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Bioderm, Inc. (Wheaton, US). The FDA issued a Cleared decision on February 6, 1995 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bioderm, Inc. devices

Submission Details

510(k) Number K946292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1994
Decision Date February 06, 1995
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -