# K220312: Polyfusion IV Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Poly Medicure Limited
- Decided: Apr 12, 2023 after 434 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 6.

## Indications for use
For administration of fluid from a container into the patient vascular system through a vascular access device.

Source page: https://510kreport.com/device/K220312
Methodology: https://510kreport.com/methodology