510(k) Report

Devices descending from K980829

4 later devices reach 3ML Steri-Neb Saline - 0.9% W/V Sodium Chloride Inhalation Solution Usp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113033Sodium Chlorde Inhalation Solution, 0.9% Usp-3MLNephron Pharmaceuticals Corp.20123—
+2K142153Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3ML;5ML;15MLTeleflexmedical, Inc.20151Class I
+2K130091PulmosalPharmacaribe201301
+3K231058Hudson RCI® AddiPak® Unit Dose VialMedline Industries, LP20240—