Cleared Traditional

PRIMADERM (K854740) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K854740 · Absorbent Cotton Co., Inc. · General & Plastic Surgery device
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Mar 1986
Decision
109d
Days
Class 1
Risk

K854740 is an FDA 510(k) clearance for the PRIMADERM. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Absorbent Cotton Co., Inc. (Hammonton, US). The FDA issued a Cleared decision on March 14, 1986 after a review of 109 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Absorbent Cotton Co., Inc. devices

Submission Details

510(k) Number K854740 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 25, 1985
Decision Date March 14, 1986
Days to Decision 109 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
6d faster than avg
Panel avg: 115d · This submission: 109d
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 9
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K854740.
TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING
K872988 · Smith & Nephew, 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