Cleared Traditional

K991818 - ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045

K991818 · Acrymed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
326d
Days
-
Risk

K991818 is an FDA 510(k) clearance for the ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044,.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Acrymed, Inc. (Portland, US). The FDA issued a Cleared decision on April 17, 2000 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Acrymed, Inc. devices

FDA 510(k) Submission Details - K991818

510(k) Number K991818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1999
Decision Date April 17, 2000
Days to Decision 326 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
211d slower than avg
Panel avg: 115d · This submission: 326d
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 K991818.
ACTICOAT 7 DRESSING
K001519 · Westaim Biomedical, 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
ACTICOAT FOAM DRESSING
K000051 · Westaim Biomedical, 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