Cleared Traditional

3M WOUND CONTACT MATERIAL, PRODUCT #563X (K881988) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K881988 · 3M Company · General & Plastic Surgery device
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Jun 1988
Decision
46d
Days
Class 1
Risk

K881988 is an FDA 510(k) clearance for the 3M WOUND CONTACT MATERIAL, PRODUCT #563X. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on June 27, 1988 after a review of 46 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 3M Company devices

Submission Details

510(k) Number K881988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1988
Decision Date June 27, 1988
Days to Decision 46 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 115d · This submission: 46d
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 106
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K881988.
TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X
K890354 · 3M Company · Apr 1989
TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING
K872988 · Smith & Nephew, Inc. · Sep 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