510(k) Report

Devices descending from K935060

33 later devices reach Brennen Medical Sterile Saline Solution through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K97218520 ML Normal Saline Topical Solution, 0.9% W/V Sodium ChlorideSteripak, Ltd.199832—
+2K053476AllwoundAt Squared, LLC20061—
+2K040683Bioderm Sciences Wound DressingBioderm Sciences, Inc.200429—
+3K211943Microlyte Ag/LidocaineImbed Biosciences20240—
+3K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc.200813—
+3K063063Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC200714—
+3K042352Bioderm Sciences Wound CreamBioderm Sciences, Inc.20051—
+3K042084Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc.200513—
+4K183662Saline Wound Wash, SteriCleanse (TM)Ascent Consumer Products, Inc.20190—
+4K141660Nawalution Skin and Wound CleanserNawa Heilmittel GmbH20142—
+4K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc.20148—
+4K123910Woundwash Saline SprayNeilmed Pharmaceuticals, Inc.20130—
+4K090848Premier Sterile Saline Wound Wash, Models 210 ML, WWMPremier Brands of America, Inc.20091—
+4K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc.20087Class I
+4K063805Silcryst Silver Antimicrobial Wound Cream, Model a-00901Nucryst Pharmaceuticals, Inc.20070—
+5K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC20260—
+5K252759revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc.20260—
+5K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH20251—
+5K231564Skin and Wound CleanserWinner Medical Co., Ltd.20230—
+5K210987IRRIGO Wound Wash Jet SystemInopro, Inc.20220—
+5K181423AMSure Sterile Water, and Sterile Normal Saline for Wound FlushAmsino International, Inc.20180—
+5K173276Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPMedline Industries, Inc.201811
+5K172486Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium…Anexa Biomedical, Inc.20171—
+5K170270Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal SalineLs Scientific Inc. D.B.A. Kse Scientific20170—
+5K161658Anexa Wound Flush, Sterile Water & Sterile Normal SalineAnexa Biomedical, Inc.20160—
+5K161311USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL…Strukmyer Medical, LLC20162—
+5K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences20163—
+5K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences20144—
+6K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+6K243001Sterile Water USP and Sterile 0.9% Normal Saline USPLaboratorios Biogalenic S.A. DE C.V.20250—
+6K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.20231—
+6K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.201701
+7K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc.20250—