# K221319: BD Alaris™ Pump Epidural Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Jul 21, 2023 after 441 days
- Product code: PWH (Administrations Sets With Neuraxial Connectors)
- 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 K031361 (2003). 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)
- K172592: CADD Yellow High Volume Administration Set with NRFit connector, Smiths Medical Asd, Inc. (2018) Summary page 4.

## Indications for use
The BD Alaris™ Pump Epidural Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through the epidural route for adults, pediatrics and neonates.

Source page: https://510kreport.com/device/K221319
Methodology: https://510kreport.com/methodology