Cleared Traditional

K960815 - DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL

K960815 is an FDA 510(k) clearance for DUPAD, manufactured by Dumex Medical Surgical Products, Ltd.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K960815 · Dumex Medical Surgical Products, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K960815

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.

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 47
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K960815.
WET CHAMBER
K020781 · Kinetic Concepts, Inc. · May 2002
KERLIX MD ANTIMICROBIAL GAUZE DRESSING
K990530 · The Kendall Company, L.P. · Jan 2000
OTOSILK OTOLOGICAL GRAFT DRESSING
K964534 · Boston Medical Products, Inc. · Apr 1997
OTOSILK
K952203 · Boston Medical Products, Inc. · Jul 1995
MEDLINE STERILE GAUZE SPONGES
K930697 · Medline Industries, Inc. · Jun 1993
FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES
K912022 · Fraass Survival Systems, Inc. · Aug 1991