# K121613: Agilia Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Kabi AG
- Decided: May 1, 2013 after 334 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904518 (1990). 22 ancestors in all.
2 later devices descend from it; 2 cite it directly.
6 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062700: Infusomat Space Volumetric Infusion Pump System, B.Braun Medical, Inc. (2006) Summary page 1.
- K083689: Infusomat Space Volumetric Infusion Pump System, B.Braun Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K210075: Vigilant Software Suite – Vigilant Master Med (2022), 0 descendants of its own
- K210073: Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo (2022), 0 descendants of its own

## Recalls of this device
- Jun 24, 2019 · Class I · Z-2064-2019: The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigil
- Dec 2, 2017 · Class II · Z-0362-2019: 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 malfunct

## Indications for use
The Agilia Infusion System is a transportable equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonates human patients to administer via a single channel or mounted on a multiple channels rack accessory: -Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but not limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration. - Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required.

Source page: https://510kreport.com/device/K121613
Methodology: https://510kreport.com/methodology