# K250325: BD Alaris Pump Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion (Bd)
- Decided: Oct 30, 2025 after 267 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: 2 generations back to K022209 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221327: BD Alaris™ Pump Infusion Sets, Care Fusion (2023) Summary page 5.

## Indications for use
The BD Alaris™ Pump Infusion Set is indicated for pump use by experienced healthcare professionals within healthcare facilities through intravenous, intra-arterial and subcutaneous routes for adults, pediatrics and neonates or irrigation of fluid spaces for adults. Based on clinical discretion these sets can be used for temporary intravenous gravity infusion.

Source page: https://510kreport.com/device/K250325
Methodology: https://510kreport.com/methodology