Cleared Traditional

K954033 - TECNOL ISLAND WOUND DRESSING

K954033 · Tecnol Medical Products, Inc. · General & Plastic Surgery device
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Sep 1995
Decision
25d
Days
-
Risk

K954033 is an FDA 510(k) clearance for the TECNOL ISLAND WOUND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Tecnol Medical Products, Inc. (Fort Worth, US). The FDA issued a Cleared decision on September 22, 1995 after a review of 25 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 Tecnol Medical Products, Inc. devices

FDA 510(k) Submission Details - K954033

510(k) Number K954033 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 28, 1995
Decision Date September 22, 1995
Days to Decision 25 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
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 17
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K954033.
3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES
K973036 · 3M Healthcare · Nov 1997
EPIVIEW
K961319 · Convatec, A Division of E.R. Squibb & Sons · Jul 1996
DERMAGRAN HYDROPHILIC WOUND DRESSING
K954738 · Derma Sciences, Inc. · Nov 1995
TECNOL TRANSPARENT WOUND DRESSING
K952504 · Tecnol Medical Products, Inc. · Jul 1995
ULTEC THIN HYDROCOLLOID DRESSING
K952071 · Sherwood Medical Co. · Jun 1995
CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS
K950065 · Conmedcorp · Mar 1995