Cleared Traditional

K952449 - TRANSAN, TRANSPARENT FILM DRESSING, TRANSPARENT WOUND DRSSING

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.

View all Medical Device Development Co. devices

FDA 510(k) Submission Details - K952449

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.

MGP Device Classification - Class 0,

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

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 59
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K952449.
DERMAGRAN HYDROPHILIC WOUND DRESSING
K954738 · Derma Sciences, Inc. · Nov 1995
TECNOL ISLAND WOUND DRESSING
K954033 · Tecnol Medical Products, Inc. · Sep 1995
SPYROFLEX WOUND DRESSING
K953618 · Polymedica Industries, Inc. · Aug 1995
TECNOL TRANSPARENT WOUND DRESSING
K952504 · Tecnol Medical Products, Inc. · Jul 1995
ULTEC THIN HYDROCOLLOID DRESSING
K952071 · Sherwood Medical Co. · Jun 1995
MITRAFLEX WOUND DRESSING WET-STICK
K952217 · Polymedica Industries, Inc. · Jun 1995