# K041241: Medley System with Bar Code Module, Model 8600

- Pathway: 510(k) (Traditional)
- Applicant: Alaris Medical Systems, Inc.
- Decided: Jul 6, 2004 after 56 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904518 (1990). 5 ancestors in all.
7 later devices descend from it; 2 cite it directly.
3 of 13 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.
- K011975: Horizon Outlook with Dosecom, B.Braun Medical, Inc. (2001) Summary page 2.

## Most influential descendants
- K050883: Safersleep System (2005), 6 descendants of its own
- K062388: Anesthesia Information and Digital-Drug Management System (2007), 5 descendants of its own
- K141474: Becton Dickinson Intelliport System (2014), 2 descendants of its own
- K182092: BD Intelliport System (2019), 1 descendant of its own
- K101439: Codonics Safe Labeling System (SLS), Model 500I/500P (2011), 1 descendant of its own

## Recalls of this device
- Feb 11, 2026 · Class II · Z-1645-2026: Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
- Dec 5, 2013 · Class I · Z-0534-2014: CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.

## Indications for use
The Medley System with Bar Code Module 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 Bar Code Module 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/K041241
Methodology: https://510kreport.com/methodology