510(k) Report

Devices descending from K830708

64 later devices reach Duo Derm Flex Hydroactive Dressings & through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984413Bionect HydrogelFidia Pharmaceutical Corp.199960—
+1K963004Bionect CreamFidia Pharmaceutical Corp.19972—
+2K172747Hyaluronic Acid Topical Wound CreamVirchow Biotech Pvt, Ltd.20180—
+2K123193Ipm Wound Gel BioGlycobiosciences, Inc.20141—
+2K123113L.a.M. Imp Wound GelGlycobiosciences, Inc.20122Class I
+2K020325L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp.200259—
+2K984262Modification of Bionect Hydrogel Gauze PadsFidia Pharmaceutical Corp.19990—
+3K143527IPM Wound Gel Bio, IPM Derm Gel BioGlycobiosciences, Inc.20150—
+3K130781L.a.M. Ipm Wound Gel, Ipm Derm GelGlycobiosciences, Inc.20141—
+3K090725Oculus Microcyn Wound GelOculus Innovative Sciences, Inc.200956—
+4K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc.201031—
+4K093697Vashe Wound Therapy SolutionPuricore, Inc.201020—
+4K093585Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc.2010251
+4K093155Vashe Wound Cleansing SystemPuricore, Inc.20100—
+5K240510Microdacyn HydrogelSonoma Pharmaceuticals, Inc.20240—
+5K153648Microcyn Plus Skin and Wound HydrogelOculus Innovative Sciences20166—
+5K150799Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Innovacyn, Inc.20159—
+5K142592CleanSmart Wound CleanserSimple Science, LLC20154—
+5K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc.201510—
+5K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences20144—
+5K133542Puracyn Plus Skin and WoundInnovacyn, Inc.201414—
+5K123072Vashe Wound Therapy SolutionPuricore, Inc.201325—
+5K113820Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals201215—
+5K102945Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc.201117—
+6K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC20260—
+6K252023MiraChlor Antimicrobial Wound SolutionLetus Corporation20260—
+6K243457Nixall Antimicrobial Solutions™ Skin & Wound HydrogelSeriously Clean, Ltd.20250—
+6K212521Field Shield Wound DressingKericure, Inc.20240—
+6K232080Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20241—
+6K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc.20195—
+6K173549BiafineValeant Pharmaceuticals20184—
+6K180305Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)Aquilabs Us, LLC20180—
+6K173896Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc.20180—
+6K171935Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc.20171—
+6K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences20163—
+6K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC20163—
+6K151168Nexodyn AOS Wound Care SolutionApr Applied Pharma Research SA20150—
+6K143590Alevicyn SG Antipruritic GelOculus Innovative Sciences20154—
+6K141660Nawalution Skin and Wound CleanserNawa Heilmittel GmbH20142—
+6K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc.20148—
+6K131542Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc.20133—
+6K123071Vashe Skin and Wound HydrogelPuricore, Inc.201311—
+7K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC20260—
+7K252759revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc.20260—
+7K251757Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20260—
+7K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH20251—
+7K251093Bonvadis®Oneness Biotech Co., Ltd.20251—
+7K232655Bonvadis®Stemcyte, Inc.20242—
+7K231564Skin and Wound CleanserWinner Medical Co., Ltd.20230—
+7K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.20231—
+7K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—
+7K190342BIAFINE Topical CreamBausch Health Americas Incorporated20190—
+7K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC20182—
+7K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.201701
+7K152945Alevicyn SG Antipruritic GelOculus Innovative Sciences20153—
+8K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+8K261638Bonvadis®Oneness Biotech Co., Ltd.20260—
+8K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc.20250—
+8K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.20241—
+8K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—
+8K162217LOYONOculus Innovative Sciences20170—
+9K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd20222—
+10K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)20260—
+10K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd20260—