# K210074: Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Kabi AG
- Decided: Mar 1, 2022 after 413 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K940147 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
6 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133532: Alaris System with Guardrails Suite MX, Carefusion 303, Inc. (2014) Summary page 5.

## Indications for use
The Agilia SP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medication, blood, and blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous, and intraosseous using dedicated administration sets. The Agilia SP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, medication, blood, and blood derivatives through clinically accepted parenteral routes of administration and critical drugs under specific conditions. These routes of administration include intravenous, intra-arterial, and subcutaneous using dedicated administration sets. It is intended for use by trained healthcare professionals in healthcare facilities

Source page: https://510kreport.com/device/K210074
Methodology: https://510kreport.com/methodology