510(k) Report

Devices descending from K925993

114 later devices reach Duoderm Hydroactive Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991202Modification to Woun'dresColoplast Corp.1999112—
+1K983042Sween Woun'dresColoplast Corp.19980—
+2K222025G4Derm / G4Derm Plus Synthetic Wound MatrixGel4med, Inc.20230—
+2K193085PuraDERM Gel3-D Matrix, Inc.20200—
+2K143058PuraDerm Gel3-D Matrix, Inc.20153—
+2K063517Healadex-PHealagenics, Inc.20073—
+2K040019SilversealNoble Fiber Technologies200497—
+2K022995Collatek HydrogelBiocore Medical Technologies, Inc.2002106—
+3K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc.20221—
+3K182681AC5 Topical GelArch Therapeutics, Inc.20181—
+3K080949Keratec Wound DressingsKeratec Limited20093—
+3K080471Radio BioaquacareBioartificial Gel Technologies (Bagtech), Inc.20080—
+3K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC200773—
+3K063063Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC200714—
+3K061227Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp.200621—
+4K241225Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC20240—
+4K190129AC5 Topical GelArch Therapeutics, Inc.20200—
+4K182010ProgenaMatrixCell Constructs I, LLC201901
+4K162759KeraStat (R) GelKeranetics, LLC20171—
+4K151185AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash…Abl Medical, LLC20160—
+4K111313Exsept Skin and Wound Cleanser with Antimicrobial PreservativeAlcavis Hdc, LLC20119—
+4K093227Silverstream and DermaseptEnzysurge, Ltd.20091—
+4K082858Exsept WC Antimicrobial Skin and Wound CleanserAlcavis International, Inc.20090—
+4K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH200918—
+4K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc.200813—
+4K073019Silvermed Antimicrobial Silver HydrogelArgentis Biomedical Incorporated20081—
+4K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc.200866—
+5K200767SilverStream GelEnzysurge, Ltd.20200—
+5K192386KeraStat CreamKeranetics20200—
+5K183662Saline Wound Wash, SteriCleanse (TM)Ascent Consumer Products, Inc.20190—
+5K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+5K170213SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH20170—
+5K163188Next Science Wound Gel (Rx)Next Science, LLC20171—
+5K160192Atteris Antimicrobial Skin & Wound CleanserRochal Industries, LLC20169—
+5K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC20163—
+5K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.20155—
+5K150792Next Science Wound GelNext Science, LLC20152—
+5K150799Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Innovacyn, Inc.20159—
+5K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc.201510—
+5K132891Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp.20140—
+5K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+5K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc.20148—
+5K123910Woundwash Saline SprayNeilmed Pharmaceuticals, Inc.20130—
+5K113693Nixall TM Wound and Skin CareSeriously Clean, Ltd.201215—
+5K113820Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals201215—
+5K101882Prontosan Antimicrobial Wound GelB.Braun Medical, Inc.201021—
+5K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc.201031—
+5K093697Vashe Wound Therapy SolutionPuricore, Inc.201020—
+5K093155Vashe Wound Cleansing SystemPuricore, Inc.20100—
+5K090791Dakin's Antimicrobial Wound Cleanser, Model 0.0125% to 5%Century Pharmaceuticals, Inc.200910—
+5K090848Premier Sterile Saline Wound Wash, Models 210 ML, WWMPremier Brands of America, Inc.20091—
+5K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc.2009373
+6K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC20260—
+6K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC20260—
+6K252028LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd.20260—
+6K252759revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc.20260—
+6K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH20251—
+6K243457Nixall Antimicrobial Solutions™ Skin & Wound HydrogelSeriously Clean, Ltd.20250—
+6K212521Field Shield Wound DressingKericure, Inc.20240—
+6K223377BIASURGE Advanced Surgical SolutionRochal Technologies, LLC20230—
+6K210987IRRIGO Wound Wash Jet SystemInopro, Inc.20220—
+6K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation20216—
+6K190224Medline Burn and Wound Dressing (OTC)Medline Industries, Inc.20190—
+6K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC20182—
+6K173911Medline Burn and Wound DressingMedline Industries, Inc.20182—
+6K180305Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)Aquilabs Us, LLC20180—
+6K171935Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc.20171—
+6K172622Microcyn Antimicrobial Skin and Wound CleanserSonoma Pharmaceuticals20173—
+6K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd.20174—
+6K163430Prontosan Wound GelB.Braun Medical, Inc.20171—
+6K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+6K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+6K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences20163—
+6K151168Nexodyn AOS Wound Care SolutionApr Applied Pharma Research SA20150—
+6K142592CleanSmart Wound CleanserSimple Science, LLC20154—
+6K141660Nawalution Skin and Wound CleanserNawa Heilmittel GmbH20142—
+6K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences20144—
+6K133542Puracyn Plus Skin and WoundInnovacyn, Inc.201414—
+6K131542Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc.20133—
+6K123072Vashe Wound Therapy SolutionPuricore, Inc.201325—
+6K110744Prontosan Wound Irrigation SolutionB.Braun Medical, Inc.20114—
+7K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH20260—
+7K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+7K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+7K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+7K254191IWD-Gel™InnovaCorium, Inc.20260—
+7K252023MiraChlor Antimicrobial Wound SolutionLetus Corporation20260—
+7K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)Huizhou Foryou Medical Devices Co., Ltd.20250—
+7K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+7K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.20241—
+7K240552Irrisept Antimicrobial Wound LavageIrrimax Corporation20240—
+7K232080Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20241—
+7K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+7K231564Skin and Wound CleanserWinner Medical Co., Ltd.20230—
+7K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+7K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.20231—
+7K220286ELECTROCYN somaV3Bio Sdn. Bhd20220—
+7K222189SiOxD Wound MatrixSioxmed, LLC20222—
+7K222804Irrisept Antimicrobial Wound LavageIrrimax Corporation20220—
+7K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—