Cleared Traditional

K092826 - ASAP ANTIMICROBIAL SILVER WOUND DRESSIN...

K092826 · American Biotech Labs · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
59d
Days
-
Risk

K092826 is an FDA 510(k) clearance for the ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by American Biotech Labs (Alexandria, US). The FDA issued a Cleared decision on November 12, 2009 after a review of 59 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 American Biotech Labs devices

FDA 510(k) Submission Details - K092826

510(k) Number K092826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2009
Decision Date November 12, 2009
Days to Decision 59 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
56d faster than avg
Panel avg: 115d · This submission: 59d
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 239
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K092826.
PRONTOSAN ANTIMICROBIAL WOUND GEL
K101882 · B.Braun Medical, Inc. · Nov 2010
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
K100218 · Coloplast A/S · Feb 2010
MEDLINE CURAD WOUND DRESSINGS
K093349 · Medline Industries, Inc. · Jan 2010
ACTICOAT FLEX 7 DRESSING
K083113 · Smith & Nephew, Inc. · Jul 2009
PROWICK
K083007 · Arthrex, Inc. · Apr 2009
PRONTOSAN ANTIMICROBIAL WOUND GEL
K090141 · B.Braun Medical, Inc. · Mar 2009