510(k) Report

Devices descending from K060944

42 later devices reach Nutrisafe 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243361NutrifitVygon USA20240—
+1K121105Nutrisafe 2 Feeding TubeVygon Corp.20120—
+1K120182Neomed Gastrointestinal Tube and AccessoriesNeomed, Inc.20120—
+1K100163Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXVygon Corp.20111—
+1K100700Med-RX Pediatric Feeding Tubes and AccessoriesBenlan, Inc.201006
+1K100099Oral/Enteral SyringesPhilips Children'S Medical Ventures201035—
+1K100366Medicina Enteral Feeding Tubes and Accessories Model MGX/YYMaxter Catheters20100—
+2K112434BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical201133—
+2K110853VR Medical Enteral Oral SyringeVr Medical20110—
+3K142128Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien201531—
+3K131183Med-RX Oral/Enteral SyringeBenlan, Inc.20140—
+4K160642Medline ENFit SyringeMedline Industries, Inc.20161—
+4K161045MonojectCovidien20163—
+4K160419Monoject Enteral Feeding Syringe with ENFit ConnectorCovidien20164—
+4K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsNeomed, Inc.201530—
+5K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe…CMT Health PTE., Ltd.20260—
+5K202285Medline ENfit OTC Feeding SyringeMedline Industries, Inc.20200—
+5K171857AMSure® Enteral Feeding Syringe with ENFit TipAmsino International, Inc.20180—
+5K170371DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3…Intervene Group Limited20170—
+5K163586Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit ConnectorTrovrx, Inc. Dba Trovita Health Science20172—
+5K161963Monoject Enteral Syringe with ENFit ConnectorCovidien20162—
+5K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…Neomed, Inc.201621—
+6K210971EnteraLoc FlowVonco Products20211—
+6K211025Oral/Enteral Syringe with ENFit connectorNingbo Tianyi Medical Appliance Co., Ltd.20212—
+6K200557Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)Jiangsu Shenli Medical Production Co., Ltd.20200—
+6K190502ENFit Oral / Enteral SyringeJiangsu Caina Medical Co.,Ltd20190Class I
+6K183540Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral…Neomed, Inc.20195—
+6K182649Enteral Feeding Syringes with Enfit ConnectorsJiangsu Kangbao Medical Equipment Co., Ltd.20181—
+6K181426Oral/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—
+6K161979ENFit enteral syringeJiangyin Caina Technology Co., Ltd.20173—
+6K161811Medela Low Dose Enteral SyringeMedela, Inc.201701
+6K160855U&U Enteral SyringeU&U Medical Technology Co, Ltd.20160—
+6K162188Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low…Vr Medical Technology20160—
+7K252483Enteral Syringe (20ml, 60ml)Chirana T.Injecta,A.S.20260—
+7K251585Profoject™ Enteral Feeding SyringeCMT Health PTE., Ltd.20250—
+7K222772Oral/Enteral Syringe with ENFit connectorAnhui Tiankang Medical Technology Co., Ltd.20230—
+7K223683EnteraLoc FlowVonco Products20230—
+7K222155O-ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe…Jiangsu Caina Medical Co.,Ltd20220—
+7K203613ENFit Reusable Enteral SyringeShantou Wealy Medical Instrument Co.,Ltd20210—
+7K203410ENFit Disposable Enteral SyringeShantou Wealy Medical Instrument Co.,Ltd20210—
+7K193657Disposable Enteral Feeding Syringe with Enfit ConnectorShinva Ande Healthcare Apparatus Co., Ltd.20201—
+8K231300Nutricair Enteral Syringe with ENFitCair Lgl20230—