ClearanceBrief
Company · DE

Fresenius Kabi USA, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2026. Name variants (Inc, Corp, punctuation) are merged.

16510(k) clearances (1 in 12 months)
30recalls (7 in 12 months)
29recalls that name a 510(k)

Product codes

CodeDeviceRecords
FRNPump, Infusion24
CACApparatus, Autotransfusion7
FPASet, Administration, Intravascular4
LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic4
GKTSeparator, Automated, Blood Cell, Diagnostic2
PHCInfusion Safety Management Software2
KPEContainer, I.V.1
LHISet, I.V. Fluid Transfer1
NZWHeparin, Vascular Access Flush1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 9, 2026K251139KabiHelp® Uno; KabiHelp® Advance plus
Fresenius Kabi AG, DE
KPE
Jun 16, 2023K221121Volumat Polyethylene I.V. Administration Set
Fresenius Kabi, DE
FPA
Jun 2, 2023K220301Volumat Line
Fresenius Kabi, DE
FPA
Jun 1, 2022K212445freeflex+ Transfer Adapter
Fresenius Kabi AG, DE
LHI
Mar 1, 2022K210075Vigilant Software Suite – Vigilant Master Med
Fresenius Kabi AG, DE
PHC
Mar 1, 2022K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
Fresenius Kabi AG, DE
FRN
Mar 1, 2022K210073Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
Fresenius Kabi AG, DE
FRN
Feb 11, 2021K210089CATSmart, Automated Blood Processing Autotransfusion System
Fresenius Kabi AG, DE
CAC
Sep 11, 2020K200530AMICUS Separator System
Fresenius Kabi AG
GKT
Nov 13, 2019K192150AMICUS Separator System
Fresenius Kabi AG, DE
LKN
Sep 27, 2019K192368CATSmart
Fresenius Kabi AG, DE
CAC
Dec 10, 2018K180831CATSmart
Fresenius Kabi AG, DE
CAC
Dec 4, 2018K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented
Fresenius Kabi USA,Llc
LKN
Nov 23, 2016K162462AMICUS Separator System, AMICUS Separator System; Refurbished
Fresenius Kabi USA,Llc
GKT
Sep 16, 2016K160735CATSmart
Fresenius Kabi AG, DE
CAC
May 1, 2013K121613AGILIA INFUSION SYSTEM
Fresenius Kabi AG
FRN

Latest recalls

DateFirm and productCodeLinked 510(k)
Jun 3, 2026Fresenius Kabi USA, LLC
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Open, Classified		 FRNK183311
May 29, 2026Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Open, Classified		 FRNK183311
May 29, 2026Fresenius Kabi USA, LLC
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Open, Classified		 FRNK183311
Jan 12, 2026Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Open, Classified		 FRNK183311
Dec 16, 2025Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Open, Classified		 FRNK183311
Dec 3, 2025Fresenius Kabi USA, LLC
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Open, Classified		 FRNK183311
Dec 1, 2025Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Open, Classified		 FRNK183311
Oct 28, 2025Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Open, Classified		 FRNK183311
Aug 1, 2025Fresenius Kabi USA, LLC
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Open, Classified		 FRNK183311
Aug 1, 2025Fresenius Kabi USA, LLC
LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
Open, Classified		 FRNK183311
Aug 1, 2025Fresenius Kabi USA, LLC
LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
Open, Classified		 FRNK183311
Aug 1, 2025Fresenius Kabi USA, LLC
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Open, Classified		 FRNK183311
Jun 6, 2025Fresenius Kabi USA, LLC
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Open, Classified		 FPAK183311
Feb 4, 2025Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted rou
Open, Classified		 FRNK183311
Jan 8, 2025Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Open, Classified		 FRNK183311
Sep 26, 2024Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Open, Classified		 FRNK183311
Sep 4, 2024Fresenius Kabi USA, LLC
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
Open, Classified		 FPAK183311
Apr 11, 2024Fresenius Kabi USA, LLC
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Open, Classified		 FRNK183311
Mar 11, 2024Fresenius Kabi USA, LLC
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Completed		 FRNK183311
Mar 11, 2024Fresenius Kabi USA, LLC
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Completed		 FRNK183311
Dec 20, 2023Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Open, Classified		 FRNK183311
Sep 25, 2023Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled admin
Open, Classified		 FRNK183311
Apr 18, 2023Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Open, Classified		 FRNK183311
Oct 6, 2022Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Terminated		 PHCK183311
Jan 29, 2015Fresenius Kabi USA, LLC
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
Terminated		 NZWK092938
May 16, 2011Fresenius Kabi, LLC
The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used f
Terminated		 LKNK961706
Dec 16, 2010Fresenius Kabi, LLC
Fresenius Red Blood Cell Set, Catalog Number 9007601. The product is labeled in part: "RBC 9007601...STERILE...FRESENIUS KABI...Made in the Netherlands". Intended use: The Fresenius RBC red blood c
Terminated		 LKNNone listed
Nov 10, 2010Fresenius Kabi, LLC
The box label states: "ATF 120 Fast Start Kit 9108501...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a phy
Terminated		 CACK960006
Nov 10, 2010Fresenius Kabi, LLC
The box label states: "ATF 40 Fast Start Kit 9108491...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a phys
Terminated		 CACK960006
Nov 10, 2010Fresenius Kabi, LLC
The box label states: "AT1 Autotransfusion Set 9005101 STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a phys
Terminated		 CACK960006
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