Cleared Traditional

K955453 - ACTICOAT SILVER COATED DRESSING

K955453 is an FDA 510(k) clearance for ACTICOAT SILVER COATED DRESSING, manufactured by Westaim Technologies, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K955453 · Westaim Technologies, Inc. · General & Plastic Surgery device
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May 1996
Decision
184d
Days
Class 1
Risk

K955453 is an FDA 510(k) clearance for the ACTICOAT SILVER COATED DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Westaim Technologies, Inc. (Washington, US). The FDA issued a Cleared decision on May 31, 1996 after a review of 184 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - 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 Westaim Technologies, Inc. devices

FDA 510(k) Submission Details - K955453

510(k) Number K955453 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 29, 1995
Decision Date May 31, 1996
Days to Decision 184 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 slower than avg
Panel avg: 115d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
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 - KMF Bandage, Liquid

All 139
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K955453.
SORBCEL ALGINATE/CMC WOUND DRESSING
K962421 · Innovative Technologies , Ltd. · Jul 1996
LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING
K961323 · Acme United Corp. · Jun 1996
ADVANCED CARE HYDROPHILIC WOUND DRESSINGS
K961662 · Mariner Biomedical, Inc. · Jun 1996
LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING
K961452 · Acme United Corp. · May 1996
MULTIDEX PLUS HYDROPHILIC WOUND DRESSING
K955399 · Lange Medical Products, Inc. · Feb 1996
3M NO STING BARRIER FILM
K955103 · 3M Medical Products Group · Feb 1996