# K072105: Alaris System with MMS, Model 8XXX

- Pathway: 510(k) (Special)
- Applicant: Cardinal Health 303,Inc.
- Decided: Dec 28, 2007 after 150 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 5 (3 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.
4 later devices descend from it; 1 cites it directly.
3 of 6 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 1.

## Most influential descendants
- K133532: Alaris System with Guardrails Suite MX (2014), 3 descendants of its own
- K211218: BD Alaris System with Guardrails Suite MX v12.1.2 (2023), 1 descendant of its own
- K243855: BD Alaris Infusion System with Guardrails Suite MX (2025), 0 descendants of its own
- K210074: Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable (2022), 0 descendants 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
- Sep 15, 2023 · Class I · Z-0185-2024: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
- Sep 15, 2023 · Class I · Z-0184-2024: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
- Sep 15, 2023 · Class I · Z-0186-2024: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
- Jan 24, 2023 · Class II · Z-1192-2023: Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective 

## Indications for use
The Alaris® System with Medication Management System (also known as the Medley™ System with MMS and the Alaris® 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 Alaris® 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/K072105
Methodology: https://510kreport.com/methodology