# K043590: SE Infusion System with MMS

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Alaris Products
- Decided: Mar 25, 2005 after 87 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K030459 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030459: Medley System with Medication Management System (MMS), Alaris Medical Systems, Inc. (2003) Summary page 2.

## Recalls of this device
- Aug 10, 2006 · Not classified · Z-1484-06: This recall was initiated because of a potential for over infusion with all models of the Alaris SE Pumps (formerly the Signature Edition Infusion Pumps) caused by key bounce.

## Indications for use
The SE Infusion System with MMS is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products. The SE Infusion System with MMS is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.

Source page: https://510kreport.com/device/K043590
Methodology: https://510kreport.com/methodology