510(k) Report

Devices descending from K013800

35 later devices reach Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251422BD Saf-T-Intima™ Subcutaneous Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.20250—
+1K210929MagiCath IIWoo Young Medical Co., Ltd.20220—
+1K192230MF SafecathMedifirst Co., Ltd.20200—
+1K151698BD Angiocath IV Catheter, BD Insyte IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20152—
+1K110443BD Insyte Autoguard BCBecton, Dickinson & CO201121—
+1K093546Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd.200927—
+1K081953Supercath 5Togo Medikit Co., Ltd.200928—
+2K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20260—
+2K230616Polyguard and Polyshield Safety IV CathetersPoly Medicure Limited20231—
+2K201075BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter…Becton, Dickinson and Company2020111
+2K182538Merit RadialFlo Arterial CatheterMerit Medical Singapore Pte., Ltd.20190—
+2K172506BD Cathena Safety IV CatheterBecton, Dickinson and Company20174—
+2K140504Accucath BC Intravascular Catheter SystemVascular Pathways, Inc.20147—
+2K140419SUPERCATH5Togo Medikit Co., Ltd.20143—
+2K130518Mini-Midline Extended Dwell Safety CatheterLuther Needlesafe Products, Inc.20130—
+2K123267Surfflash (R) Plus Safety I.V. CatheterKofu Factory of Terumo Corp.20120—
+2K112290Supercath Z3VTogo Medikit Co., Ltd.20124—
+2K113700Viavalve Safety IV CatheterSmiths Medical Asd, Inc.20121—
+3K252677Polyshield Safety IV CathetersPoly Medicure Limited20250—
+3K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV…Becton Dickinson Infusion Therapy Systems, Inc.20250—
+3K192493BD Cathena (TM) Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20203—
+3K190001Supercath 5Togo Medikit Co., Ltd.20190—
+3K172496Supercath 5 (26G)Togo Medikit Co., Ltd.20181—
+3K160592Supercath 6Togo Medikit Co., Ltd.20160—
+3K160235ViaValve Safety I.V. CatheterSmiths Medical Asd, Inc.201601
+3K153298AccuCath Intravascular CatheterC.R. Bard, Inc.20155—
+3K142136Accucath Midline Catheter SystemVascular Pathways, Inc.20150—
+4K201717BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20202—
+4K162894AccuCath Intravascular CatheterC.R. Bard, Inc.20164—
+5K243105Ruby Intravascular CatheterVenocare, Inc.20251—
+5K233106AccuCath Ace™ Intravascular CatheterBard Access Systems, Inc. (C.R. Bard, Inc.)20240—
+5K220584BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.202212
+5K191232AccuCath Ace Intravascular CatheterC.R. Bard, Inc.20190—
+6K260432Ruby Intravascular CatheterVenocare, Inc.20260—
+6K251155BD Cathena™ Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20250—