Cleared Traditional

K001519 - ACTICOAT 7 DRESSING

K001519 · Westaim Biomedical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
143d
Days
-
Risk

K001519 is an FDA 510(k) clearance for the ACTICOAT 7 DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Westaim Biomedical, Inc. (Exeter, US). The FDA issued a Cleared decision on October 6, 2000 after a review of 143 days - within the typical 510(k) review window.

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: 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 Biomedical, Inc. devices

FDA 510(k) Submission Details - K001519

510(k) Number K001519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2000
Decision Date October 06, 2000
Days to Decision 143 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
28d slower than avg
Panel avg: 115d · This submission: 143d
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 K001519.
ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING
K002896 · The Westaim Corp. · Feb 2001
ACTICOAT COMPOSITE DRESSING
K002466 · Westaim Biomedical, Inc. · Feb 2001
ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103
K002909 · Acrymed, Inc. · Oct 2000
MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
K002599 · Acrymed, Inc. · Sep 2000
ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
K992221 · Westaim Biomedical, Inc. · Jun 2000
ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
K991818 · Acrymed, Inc. · Apr 2000