# K043299: Medley Pca Module, Model 8120

- Pathway: 510(k) (Traditional)
- Applicant: Alaris Medical Systems, Inc.
- Decided: Dec 10, 2004 after 10 days
- Product code: MEA (Pump, Infusion, Pca)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K032233 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032233: Medley Pca Module, Model 8120, Alaris Medical Systems, Inc. (2003) Summary page 5.

## Recalls of this device
- Aug 4, 2020 · Class I · Z-2882-2020: The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.
- Mar 5, 2008 · Not classified · Z-1712-2008: A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failure of the U9 Socketed Integrated Circuits 
- Mar 5, 2008 · Not classified · Z-1711-2008: A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors with the Alaris System due to the Inter-Unit Interface

## Indications for use
The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices 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. The addition of the PCA/Monitoring Protocol provides an optional and hospital-configurable feature that is intended to align with healthcare facilities' current protocols that require monitoring of patients while on PCA therapy. All device programming, data entry and validation of PCA/Monitoring Protocol parameters is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order.

Source page: https://510kreport.com/device/K043299
Methodology: https://510kreport.com/methodology