510(k) Report

Devices descending from K183540

5 later devices reach Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe…CMT Health PTE., Ltd.20260—
+1K222155O-ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe…Jiangsu Caina Medical Co.,Ltd20220—
+1K203613ENFit Reusable Enteral SyringeShantou Wealy Medical Instrument Co.,Ltd20210—
+1K210971EnteraLoc FlowVonco Products20211—
+2K223683EnteraLoc FlowVonco Products20230—