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
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 242
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K000051.
CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
K033869 · Coloplast Corp. · May 2004
CONTREET FOAM ADHESIVE/NON-ADHESIVE
K022416 · Coloplast Corp. · Feb 2003
ABSORBENT ANTIMICROBIAL WOUND DRESSING
K013814 · Convatec, A Division of E.R. Squibb & Sons · Jun 2002
COMPEED PSORIASIS DRESSING
K982493 · Coloplast Corp. · Jan 1999
BIATAIN FOAM DRESSING
K983163 · Coloplast Corp. · Dec 1998
BIATAIN FOAM ADHESIVE DRESSING
K983173 · Coloplast Corp. · Dec 1998