510(k) Report

Devices descending from K991758

3 later devices reach Monoject Insulin Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160589Certa Dose PD Epinephrine 1mg/mL IM/SC SyringeCerta Dose, Inc.20170—
+1K081547Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc.20080—
+1K033373Monoject Insulin SyringeTyco Healthcare200301