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KPE — Container, I.V. Class II

FDA Device Classification

Classification Details

Product Code
KPE
Device Class
Class II
Regulation Number
880.5025
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251139fresenius kabiKabiHelp® Uno; KabiHelp® Advance plusJanuary 9, 2026
K252094epic medical pte.eZSURE™ Empty Fluid ContainerAugust 1, 2025
K250459technoflexDMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 5April 18, 2025
K241442epic medical pte.eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteJune 21, 2024
K223674epic medical pte.eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)September 1, 2023
K222622beijing l and z medical technology development coDisposable Infusion Bag for Parenteral NutritionFebruary 16, 2023
K210749haemotronicEmpty EVA BagAugust 19, 2021
K201936gileroSmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLMay 6, 2021
K193528haemotronicEmpty EVA BagJuly 22, 2020
K190328health care technologiesHCT Empty EVA Container PackAugust 15, 2019
K190305international medical industriesAdditive CapApril 30, 2019
K181393valmedEmpty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVMFebruary 15, 2019
K132276hospiraSTERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STENovember 12, 2013
K121161acta medicalEMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINERJuly 13, 2012
K111217baxter healthcareADDITIVE CAPJune 14, 2011
K101412valmedEVA TPN BAGApril 13, 2011
K090096baxter healthcare corporationALL-IN-ONE CONTAINERJanuary 30, 2009
K073538b.braun medicalDUAL CHAMBER TPN CONTAINERMarch 12, 2008
K061197kawasumi laboratoriesKAWASUMI LABORATORIES EMPTY SOLUTION CONTAINERJune 30, 2006
K041038churchill medical systemsCHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINERDecember 21, 2004