510(k) Report

Devices descending from K760584

4 later devices reach U-Mid Prefilled Humidifier (500CC) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090915Sterile Water for Inhalation Flex Bag, UspCardinal Health, Inc.20093—
+2K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.20260—
+2K223551Sterile Water for Inhalation in 1L Flexoval ® bottles.Hometa, Inc.20231—
+3K242717Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.20250—