Cleared Traditional

DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL (K960815) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K960815 · Dumex Medical Surgical Products, Ltd. · General & Plastic Surgery device
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Apr 1996
Decision
61d
Days
Class 1
Risk

K960815 is an FDA 510(k) clearance for the DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRES.... Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Dumex Medical Surgical Products, Ltd. (Toronto, Orntario, CA). The FDA issued a Cleared decision on April 29, 1996 after a review of 61 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 Dumex Medical Surgical Products, Ltd. devices

Submission Details

510(k) Number K960815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1996
Decision Date April 29, 1996
Days to Decision 61 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
54d faster than avg
Panel avg: 115d · This submission: 61d
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 K960815.
MEDLINE STERILE GAUZE SPONGES
K930697 · Medline Industries, Inc. · Jun 1993
TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X
K890354 · 3M Company · Apr 1989
3M WOUND CONTACT MATERIAL, PRODUCT #563X
K881988 · 3M Company · Jun 1988
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