Data / Medical devices / United States / Fresenius Kabi Warrendale

Fresenius Kabi Warrendale: FDA-registered device maker in Warrendale, PA, United States, 6 510(k) clearances

Name: Fresenius Kabi Warrendale FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Fresenius Kabi Warrendale is registered with the FDA (registration 3005778453) in Warrendale, PA, United States. It lists 12 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 11, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3005778453
Address: 770 Commonwealth Dr, Warrendale, PA, United States, 15086
Owner or operator: Fresenius Kabi AG (9027285)
Roles: Manufacturer, Manufacturer for export, Remanufacturer
First device listed: June 1, 1999
Registered through: 2026
Brand names listed: ALYX 2 RBC-LR Kit, ALYX 2RBC DISPOSABLE SET, ALYX 2RBC LR Kit with Saline Spike, ALYX 2RBC-LR Kit, ALYX COMPONENT COLLECTION SYSTEM, ALYX COMPONENT COLLECTION SYSTEM (4R5707, 4R5725), ALYX COMPONENT COLLECTION SYSTEM (6R5725), ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL) and more

Devices it lists

Device	Product code	Class	Role	Source
Blood Establishment Computer Software And Accessories	MMH	2	Manufacturer	accessdata.fda.gov
Bone Marrow Collection/Transfusion Kit	LWE	2	Manufacturer	accessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1	Manufacturer	accessdata.fda.gov
Device, Blood Mixing And Blood Weighing	KSQ	1	Manufacturer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Manufacturer	accessdata.fda.gov
Infusion Safety Management Software	PHC	2	Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Pump, Infusion	FRN	2	Manufacturer, Remanufacturer	accessdata.fda.gov
Separator, Automated, Blood Cell And Plasma, Therapeutic	LKN	U	Manufacturer	accessdata.fda.gov
Separator, Automated, Blood Cell, Diagnostic	GKT	2	Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Manufacturer, Remanufacturer	accessdata.fda.gov
Supplies, Blood-Bank	KSS	1	Manufacturer	accessdata.fda.gov
System, Photopheresis, Extracorporeal	LNR	3	Manufacturer for export	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 11, 2020	K200530	AMICUS Separator System	GKT	Substantially Equivalent	Fresenius Kabi AG	accessdata.fda.gov
November 13, 2019	K192150	AMICUS Separator System	LKN	Substantially Equivalent	Fresenius Kabi AG	accessdata.fda.gov
June 7, 2019	K183311	Ivenix Infusion System (IIS)	FRN	Substantially Equivalent	Ivenix, Inc.	accessdata.fda.gov
December 4, 2018	K180615	AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter	LKN	Substantially Equivalent	Fresenius Kabi USA,Llc	accessdata.fda.gov
November 23, 2016	K162462	AMICUS Separator System, AMICUS Separator System; Refurbished	GKT	Substantially Equivalent	Fresenius Kabi USA,Llc	accessdata.fda.gov
November 6, 1987	K871198	BONE MARROW COLLECTION KIT AND STAND	LWE	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 1, 2013	65080	Class II	Terminated	2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemi	Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, and the 2008 MeDS pump tubing Set for CombiSet Bloodlines can lead to a situation where Venofer(R) delivery does not meet dosage accuracy requirements. This may lead to a slight over or under delivery of Venofer(R) that does not pose an acceptable risk to the pat	accessdata.fda.gov

Compare with other makers

Updated September 11, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.