Cleared Traditional

DERMATEC BURN PADS (K863379) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K863379 · Dermatec, Inc. · General & Plastic Surgery device

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Sep 1986

Decision

23d

Days

Class 1

Risk

K863379 is an FDA 510(k) clearance for the DERMATEC BURN PADS. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Dermatec, Inc. (Stratford, US). The FDA issued a Cleared decision on September 26, 1986 after a review of 23 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

Submission Details

510(k) Number	K863379 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	September 03, 1986
Decision Date	September 26, 1986
Days to Decision	23 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

92d faster than avg

Panel avg: 115d · This submission: 23d

Pathway characteristics

Predicate-based equivalence.

Device Classification

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 11

Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K863379.

STRETCH GAUZE BANDAGES

K872875 · Abco Dealers, Inc. · Sep 1987

JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING

K872982 · Johnson & Johnson Professionals, Inc. · Aug 1987

ALLEVYN HYDROPHILIC POLYURETHANE DRESSING

K871166 · Smith & Nephew, Inc. · Jun 1987

OPSITE WOUND DRESSING

K852211 · Smith & Nephew, Inc. · Jul 1985

HYPAFIX POST OPERATIVE DRESSING

K850282 · Smith & Nephew, Inc. · May 1985

LASTOBAND ADHESIVE BANDAGES

K831454 · Smith & Nephew, Inc. · Oct 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K863379

Dermatec, Inc.

Stratford, CT · US

STEVEN M TUCHBAND

Regulatory profile

4 submissions 1 cleared

25% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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