# K221121: Volumat Polyethylene I.V. Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Kabi
- Decided: Jun 16, 2023 after 424 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003225 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203609: Intravascular Administration Sets, Baxter Healthcare Corporation (2021) Summary page 5.

## Indications for use
I.V. Administration Set for the infusion of parenteral fluids and medications from a container into the patient’s vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.

Source page: https://510kreport.com/device/K221121
Methodology: https://510kreport.com/methodology