# K030459: Medley System with Medication Management System (MMS)

- Pathway: 510(k) (Traditional)
- Applicant: Alaris Medical Systems, Inc.
- Decided: Apr 4, 2003 after 52 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
73 later devices descend from it; 9 cite it directly.
21 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Horizon Outlook with DoseCom: named in the summary without a submission number

## Most influential descendants
- K042121: Spectrum and Spectrum with Master Drug Library (2004), 28 descendants of its own
- K133801: Baxter Sigma Spectrum Infusion Pump with Master Drug Library (2014), 18 descendants of its own
- K062700: Infusomat Space Volumetric Infusion Pump System (2006), 15 descendants of its own
- K173084: Spectrum IQ Infusion System, Dose IQ Safety Software (2018), 9 descendants of its own
- K123049: Sapphire Infusion Pump (2013), 7 descendants of its own

## Indications for use
The ALARIS Medical Systems, Inc., Medley™ System with Medication Management System (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 Medley™ 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/K030459
Methodology: https://510kreport.com/methodology