510(k) Report

Devices descending from K880411

7 later devices reach Dey-Vial Sodium Chloride Solution, Usp, Sterile through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972778Dey Vial Sodium Chloride 3%Dey Laboratories, Inc.19976—
+2K120051Sodium Chloride Inhalation Solution, 3%, 7%, and 10%, Usp-4MLNephron Pharmaceuticals Corp.201202
+2K101424Pharmacaribe Inhaled Saline SolutionsPharmacaribe20104—
+2K070498Hyper SalPari Innovative Manufacturers, Inc.20075—
+3K232523Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%Mankind Pharma Limited20240—
+3K210126Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%The Ritedose Corporation20210—
+3K130091PulmosalPharmacaribe201301