# K032233: Medley Pca Module, Model 8120

- Pathway: 510(k) (Traditional)
- Applicant: Alaris Medical Systems, Inc.
- Decided: Sep 9, 2003 after 50 days
- Product code: MEA (Pump, Infusion, Pca)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 3 cite it directly.
4 of 9 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 no predicate by number.

## Most influential descendants
- K083689: Infusomat Space Volumetric Infusion Pump System (2009), 4 descendants of its own
- K121613: Agilia Infusion System (2013), 2 descendants of its own
- K092313: Perfusor Space Infusion Syringe Pump System (2009), 1 descendant of its own
- K210075: Vigilant Software Suite – Vigilant Master Med (2022), 0 descendants of its own
- K210073: Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo (2022), 0 descendants of its own

## Recalls of this device
- Nov 17, 2017 · Class II · Z-0323-2018: The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
- Jun 12, 2009 · Not classified · Z-1794-2009: There is a potential risk of IUI connector failure in the Alaris System when these connectors become corroded or contaminated, which may result in an interruption of infusion with an audible and visua
- Mar 4, 2009 · Not classified · Z-1237-2009: The Alaris PCA module can potentially infuse above or below the intended infusion dose.

## Indications for use
The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of medications or fluids. The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), subcutaneous, or epidural.

Source page: https://510kreport.com/device/K032233
Methodology: https://510kreport.com/methodology