510(k) Report

Devices descending from K851090

5 later devices reach Monoject Sterile 1/2 CC & 1CC Syringes W & W/O Nee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180683Certa Dose Pediatric Midazolam 5mg/mL IM SyringeCerta Dose, Inc.20180—
+1K081547Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc.20080—
+1K991758Monoject Insulin SyringeThe Kendal Co.19993—
+2K160589Certa Dose PD Epinephrine 1mg/mL IM/SC SyringeCerta Dose, Inc.20170—
+2K033373Monoject Insulin SyringeTyco Healthcare200301