Cleared Traditional

K955863 - ALLDRESS MULTI LAYERED WOUND DRESSING

K955863 is an FDA 510(k) clearance for ALLDRESS MULTI LAYERED WOUND DRESSING, manufactured by Molnlycke/Scott Health Care. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K955863 · Molnlycke/Scott Health Care · General & Plastic Surgery device
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Mar 1996
Decision
77d
Days
Class 1
Risk

K955863 is an FDA 510(k) clearance for the ALLDRESS MULTI LAYERED WOUND DRESSING. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Molnlycke/Scott Health Care (Fort Worth, US). The FDA issued a Cleared decision on March 13, 1996 after a review of 77 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 Molnlycke/Scott Health Care devices

FDA 510(k) Submission Details - K955863

510(k) Number K955863 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 27, 1995
Decision Date March 13, 1996
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 44
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K955863.
WET CHAMBER
K020781 · Kinetic Concepts, Inc. · May 2002
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
MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS
K901853 · Johnson & Johnson Medical, Inc. · Jan 1991