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Fresenius Vial S.A.S.: FDA-registered device maker in Brezins Isere, France, 3 510(k) clearances

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

Fresenius Vial S.A.S. is registered with the FDA (registration 3000240707) in Brezins Isere, France. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 1, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3000240707
Address: Le Grand Chemin, Brezins Isere, France, F-38590
Owner or operator: Fresenius Kabi AG (9027285)
Roles: Manufacturer
First device listed: May 9, 2022
Registered through: 2026
Brand names listed: Agilia SP Infusion System, Agilia VP MC WiFi, VSS Vigilant Master Med

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Pump, Infusion	MRZ	2	Manufacturer	accessdata.fda.gov
Infusion Safety Management Software	PHC	2	Manufacturer	accessdata.fda.gov
Pump, Infusion	FRN	2	Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Manufacturer	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
March 1, 2022	K210075	Vigilant Software Suite Vigilant Master Med	PHC	Substantially Equivalent	Fresenius Kabi AG	accessdata.fda.gov
March 1, 2022	K210074	Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable	FRN	Substantially Equivalent	Fresenius Kabi AG	accessdata.fda.gov
March 1, 2022	K210073	Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo	FRN	Substantially Equivalent	Fresenius Kabi AG	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
December 2, 2017	81208	Class II	Terminated	Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities enviro	Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusion Pump because it was designed to improve customer experience while preventing common software malfunctions.	accessdata.fda.gov

Compare with other makers

Updated March 1, 2022. 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.