510(k) Report

Devices descending from K101677

30 later devices reach Hospira Infusion Blood Sets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143082IV Administration Sets with 200(micro)m Blood FilterB.Braun Medical, Inc.20151—
+1K143087Hospira Blood SetHospira, Inc.20152—
+1K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for…Hospira, Inc.20159Class I
+1K142974Extension SetsHospira, Inc.20154—
+1K142433Hospira Extension SetHospira, Inc.20143—
+1K140838IV Administration Set with Hand PumpB.Braun Medical, Inc.20146—
+1K142367Hospira Primary SetsHospira, Inc.201441
+1K113683Lifeshield Vision Infusion Set with Pre-Pierced ResealHospira, Inc.201219—
+2K213846Q2 Blood Administration SetsQuest Medical, Inc.20220—
+2K170595IV Administration SetsB.Braun Medical, Inc.2017319
+2K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc.20175Class I
+2K161036Hospira Extension Set, Hospira Primary SetHospira, Inc.20170—
+2K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC20161—
+2K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…Covidien201625
+2K160870Hospira Administration SetsHospira, Inc.20161—
+2K151969Hospira Extension SetsIcu Medical, Inc.20160—
+2K143015Hospira Primary SetsHospira, Inc.20153—
+2K142622IV AdministrationHospira, Inc.201521
+3K253558Luminoah FLOW™ Enteral Nutrition SystemLuminoah20260—
+3K223607Plum Duo™ Infusion SystemIcu Medical, Inc.20232Class I
+3K221603Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD…Cardinal Health, LLC20220—
+3K213588Q2 IV Administration SetsQuest Medical, Inc.20220—
+3K202618IV Administration SetsB.Braun Medical, Inc.202101
+3K192375Intellifuse Administration and Intellifuse Blood Administration SetsSmiths Medical Asd, Inc.20200—
+3K191362LifeFlow Blood System410 Medical, Inc.20200—
+3K191658IV Sets not made with PVCB.Braun Medical, Inc.202001
+3K183311Ivenix Infusion System (IIS)Ivenix, Inc.20191Class I
+4K242114Plum Solo™ Precision IV PumpIcu Medical, Inc.202503
+4K242115Plum Duo™ Precision IV PumpIcu Medical, Inc.202502
+4K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorIvenix, Inc.20210—