Cleared Traditional

K090791 - DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%

K090791 · Century Pharmaceuticals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
136d
Days
-
Risk

K090791 is an FDA 510(k) clearance for the DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Century Pharmaceuticals, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on August 7, 2009 after a review of 136 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 Century Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K090791

510(k) Number K090791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2009
Decision Date August 07, 2009
Days to Decision 136 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
21d slower than avg
Panel avg: 115d · This submission: 136d
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 610
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K090791.
MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014
K092232 · Puricore, Inc. · Aug 2009
TT-102
K081246 · Tissue Technologies Holdings, LLC · Aug 2009
TROPAZONE LOTION
K090337 · Midlothian Laboratories · Aug 2009
ELASTO-GEL MANUKA HONEY WOUND DRESSING
K083334 · Southwest Technologies, Inc. · Jul 2009
EXSALT SD7 WOUND DRESSING
K083870 · Exciton Technologies, Inc. · Jul 2009
SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND
K091013 · Advanced Medical Solutions Limited · Jul 2009