510(k) Report

Devices descending from K090915

3 later devices reach Sterile Water for Inhalation Flex Bag, Usp through their predicates, nearest generation first.

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