Cleared Traditional

TRANSAN, TRANSPARENT FILM DRESSING, TRANSPARENT WOUND DRSSING (K952449) - FDA 510(k) Clearance

K952449 · Medical Device Development Co. · General & Plastic Surgery device
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Aug 1995
Decision
74d
Days
-
Risk

K952449 is an FDA 510(k) clearance for the TRANSAN, TRANSPARENT FILM DRESSING, TRANSPARENT WOUND DRSSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Medical Device Development Co. (Bangor, US). The FDA issued a Cleared decision on August 7, 1995 after a review of 74 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.

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Submission Details

510(k) Number K952449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1995
Decision Date August 07, 1995
Days to Decision 74 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
41d faster than avg
Panel avg: 115d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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