# K221327: BD Alaris™ Pump Infusion Sets

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Jul 21, 2023 after 441 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: 1 generation back to K022209 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022209: Alaris Medical Infusion System Administration Sets, Alaris Medical Systems, Inc. (2002) Summary page 4.

## Most influential descendants
- K250325: BD Alaris Pump Infusion Set (2025), 0 descendants of its own

## Indications for use
The BD Alaris™ Pump Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through intravenous, intra-arterial and subcutaneous routes for adults, pediatrics and neonates or irrigation of fluid spaces for adults.

Source page: https://510kreport.com/device/K221327
Methodology: https://510kreport.com/methodology