Cleared Traditional

DUKAL TRANSPARENT WOUND DRESSING (K955476) - FDA 510(k) Clearance

K955476 · Dukal Corp. · General & Plastic Surgery device
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Jan 1996
Decision
49d
Days
-
Risk

K955476 is an FDA 510(k) clearance for the DUKAL TRANSPARENT WOUND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Dukal Corp. (Palm Harobor, US). The FDA issued a Cleared decision on January 18, 1996 after a review of 49 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 Dukal Corp. devices

Submission Details

510(k) Number K955476 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 30, 1995
Decision Date January 18, 1996
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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