510(k) Report

Devices descending from K100099

35 later devices reach Oral/Enteral Syringes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112434BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical201133—
+1K110853VR Medical Enteral Oral SyringeVr Medical20110—
+2K142128Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien201531—
+2K131183Med-RX Oral/Enteral SyringeBenlan, Inc.20140—
+3K160642Medline ENFit SyringeMedline Industries, Inc.20161—
+3K161045MonojectCovidien20163—
+3K160419Monoject Enteral Feeding Syringe with ENFit ConnectorCovidien20164—
+3K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsNeomed, Inc.201530—
+4K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe…CMT Health PTE., Ltd.20260—
+4K202285Medline ENfit OTC Feeding SyringeMedline Industries, Inc.20200—
+4K171857AMSure® Enteral Feeding Syringe with ENFit TipAmsino International, Inc.20180—
+4K170371DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3…Intervene Group Limited20170—
+4K163586Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit ConnectorTrovrx, Inc. Dba Trovita Health Science20172—
+4K161963Monoject Enteral Syringe with ENFit ConnectorCovidien20162—
+4K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…Neomed, Inc.201621—
+5K210971EnteraLoc FlowVonco Products20211—
+5K211025Oral/Enteral Syringe with ENFit connectorNingbo Tianyi Medical Appliance Co., Ltd.20212—
+5K200557Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)Jiangsu Shenli Medical Production Co., Ltd.20200—
+5K190502ENFit Oral / Enteral SyringeJiangsu Caina Medical Co.,Ltd20190Class I
+5K183540Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral…Neomed, Inc.20195—
+5K182649Enteral Feeding Syringes with Enfit ConnectorsJiangsu Kangbao Medical Equipment Co., Ltd.20181—
+5K181426Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)Jiangsu Micsafe Medical Technology Co., Ltd.20180—
+5K161979ENFit enteral syringeJiangyin Caina Technology Co., Ltd.20173—
+5K161811Medela Low Dose Enteral SyringeMedela, Inc.201701
+5K160855U&U Enteral SyringeU&U Medical Technology Co, Ltd.20160—
+5K162188Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low…Vr Medical Technology20160—
+6K252483Enteral Syringe (20ml, 60ml)Chirana T.Injecta,A.S.20260—
+6K251585Profoject™ Enteral Feeding SyringeCMT Health PTE., Ltd.20250—
+6K222772Oral/Enteral Syringe with ENFit connectorAnhui Tiankang Medical Technology Co., Ltd.20230—
+6K223683EnteraLoc FlowVonco Products20230—
+6K222155O-ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe…Jiangsu Caina Medical Co.,Ltd20220—
+6K203613ENFit Reusable Enteral SyringeShantou Wealy Medical Instrument Co.,Ltd20210—
+6K203410ENFit Disposable Enteral SyringeShantou Wealy Medical Instrument Co.,Ltd20210—
+6K193657Disposable Enteral Feeding Syringe with Enfit ConnectorShinva Ande Healthcare Apparatus Co., Ltd.20201—
+7K231300Nutricair Enteral Syringe with ENFitCair Lgl20230—