Cleared Traditional

K863578 - DERMATEC ZONE TRANSPARENT DRESSING

K863578 is an FDA 510(k) clearance for DERMATEC ZONE TRANSPARENT DRESSING, manufactured by Dermatec, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K863578 · Dermatec, Inc. · General & Plastic Surgery device
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Nov 1986
Decision
89d
Days
Class 1
Risk

K863578 is an FDA 510(k) clearance for the DERMATEC ZONE TRANSPARENT DRESSING. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Dermatec, Inc. (Trumbull, US). The FDA issued a Cleared decision on November 25, 1986 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - the FDA general and plastic surgery device framework. 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 Dermatec, Inc. devices

FDA 510(k) Submission Details - K863578

510(k) Number K863578 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 28, 1986
Decision Date November 25, 1986
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NAD Dressing, Wound, Occlusive

All 56
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K863578.
BANDAGES CATALOG NUMBER: 101 TO 220
K871495 · I M, Inc. · May 1987
BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE)
K870185 · Fraass Survival Systems, Inc. · Feb 1987
DRESSING, BURN, 24 BY 36 INCHES
K870239 · Fraass Survival Systems, Inc. · Feb 1987
EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES
K864011 · Fraass Survival Systems, Inc. · Nov 1986
WOUND MANAGER(TM) - STERILE
K862935 · Convatec, A Division of E.R. Squibb & Sons · Aug 1986
LYOFOAM WOUND DRESSINGS
K860085 · Acme United Corp. · Jun 1986