Cleared Traditional

K091354 - ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING

K091354 · Acrymed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
166d
Days
-
Risk

K091354 is an FDA 510(k) clearance for the ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Acrymed, Inc. (Beaverton, US). The FDA issued a Cleared decision on October 21, 2009 after a review of 166 days - an extended review 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: 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 Acrymed, Inc. devices

FDA 510(k) Submission Details - K091354

510(k) Number K091354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2009
Decision Date October 21, 2009
Days to Decision 166 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 115d · This submission: 166d
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 K091354.
HYLATOPIC PLUS EMOLLIENT FOAM
K093051 · Collegium Pharmaceutical Incorporated · Dec 2009
ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL
K092826 · American Biotech Labs · Nov 2009
SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS
K083133 · Andover Healthcare, Inc. · Oct 2009
ELETONE CREAM
K092297 · Ferndale Pharma Group, Inc. · Oct 2009
SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)
K090254 · Convatec, A Division of E.R. Squibb & Sons, LLC · Sep 2009
MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014
K092232 · Puricore, Inc. · Aug 2009