Cleared Traditional

K000051 - ACTICOAT FOAM DRESSING

K000051 · Westaim Biomedical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
89d
Days
-
Risk

K000051 is an FDA 510(k) clearance for the ACTICOAT FOAM DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Westaim Biomedical, Inc. (Exeter, US). The FDA issued a Cleared decision on April 5, 2000 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Westaim Biomedical, Inc. devices

FDA 510(k) Submission Details - K000051

510(k) Number K000051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2000
Decision Date April 05, 2000
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 607
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K000051.
MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
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K992221 · Westaim Biomedical, Inc. · Jun 2000
ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
K991818 · Acrymed, Inc. · Apr 2000
SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
K993969 · Winchester Laboratories, LLC · Dec 1999
ANTIBACTERIAL ADHESIVE BANDAGE
K992817 · William Feinstein & Associates, Inc. · Nov 1999
SILVERLON WOUND PACKING STRIPS
K984210 · Argentum International, LLC · Sep 1999