510(k) Report

Devices descending from K030467

57 later devices reach Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063239Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 &…Hospira, Inc.2006567
+2K101677Hospira Infusion Blood SetsHospira, Inc.201030Class I
+2K080579Effectiv (TM) CapHospira, Inc.200824—
+3K143082IV Administration Sets with 200(micro)m Blood FilterB.Braun Medical, Inc.20151—
+3K143087Hospira Blood SetHospira, Inc.20152—
+3K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for…Hospira, Inc.20159Class I
+3K142974Extension SetsHospira, Inc.20154—
+3K142433Hospira Extension SetHospira, Inc.20143—
+3K140838IV Administration Set with Hand PumpB.Braun Medical, Inc.20146—
+3K142367Hospira Primary SetsHospira, Inc.201441
+3K113683Lifeshield Vision Infusion Set with Pre-Pierced ResealHospira, Inc.201219—
+3K093229Catheter Connections DualcapCatheter Connections, Inc.20108—
+3K083508SwabcapExcelsior Medical Corp.200923—
+4K213846Q2 Blood Administration SetsQuest Medical, Inc.20220—
+4K170595IV Administration SetsB.Braun Medical, Inc.2017319
+4K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc.20175Class I
+4K161036Hospira Extension Set, Hospira Primary SetHospira, Inc.20170—
+4K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC20161—
+4K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…Covidien201625
+4K160870Hospira Administration SetsHospira, Inc.20161—
+4K151969Hospira Extension SetsIcu Medical, Inc.20160—
+4K142806DualCapCatheter Connections, Inc.20151—
+4K143015Hospira Primary SetsHospira, Inc.20153—
+4K142622IV AdministrationHospira, Inc.201521
+4K130975Swabcap and SwabflushExcelsior Medical Corp.201322
+4K121655BD Alcohol SwabBecton, Dickinson & CO20131—
+4K123967Catheter Connections' Dark Blue Dualcap for Male LuersCatheter Connections, Inc.20130—
+4K121171Curos TipIvera Medical, Inc.20120—
+4K112791Sitescrub Ipa DeviceC. R. Bard20123—
+4K113842Catheter Connections' Dualcap SoloCatheter Connections, Inc.20122—
+4K111992Curos Port ProtectorIvera Medical, Inc.20126—
+4K112985Catheter Connections' Dualcap DuoCatheter Connections, Inc.20110—
+4K101270Swabflsuh (3ML, 5ML, 10ML) Model 10331, 10351, 10311Excelsior Medical Corp.20110—
+5K253558Luminoah FLOW™ Enteral Nutrition SystemLuminoah20260—
+5K252006OTTO™ Disinfecting CapIcu Medical, Inc.20260—
+5K223914ACTIV™ CapCleansite Medical, Inc.20240—
+5K223607Plum Duo™ Infusion SystemIcu Medical, Inc.20232Class I
+5K221603Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD…Cardinal Health, LLC20220—
+5K2139550.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrubBecton, Dickinson and Company20220—
+5K213588Q2 IV Administration SetsQuest Medical, Inc.20220—
+5K202618IV Administration SetsB.Braun Medical, Inc.202101
+5K193190BD PureHub Disinfecting CapBecton, Dickinson and Company20201—
+5K200299Curos Jet Disinfecting Cap3M Company20200—
+5K192375Intellifuse Administration and Intellifuse Blood Administration SetsSmiths Medical Asd, Inc.20200—
+5K191362LifeFlow Blood System410 Medical, Inc.20200—
+5K191658IV Sets not made with PVCB.Braun Medical, Inc.202001
+5K190918SwabTip Male Disinfectant CapIcu Medical20200—
+5K183311Ivenix Infusion System (IIS)Ivenix, Inc.20191Class I
+5K151620Firefly Peritoneal Dialysis Connector Disinfection SystemPuracath Medical, Inc.20160—
+5K140657Curos Red Port ProtectorIvera Medical, Inc.20140—
+5K132380Prevantics Device SwabProfessional Disposables International, Inc.20140—
+5K123065Catheter Connections Dualcap SoloCatheter Connections, Inc.201211
+6K251592SteriHub™ Disinfecting Device and Protective Cover1World Vista Medical20260—
+6K242114Plum Solo™ Precision IV PumpIcu Medical, Inc.202503
+6K242115Plum Duo™ Precision IV PumpIcu Medical, Inc.202502
+6K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorIvenix, Inc.20210—
+6K192382CapKlenZStar Mountain Medical, Inc.20200—