# K023264: Medley Syringe Pump Module System, Model 8110

- Pathway: 510(k) (Traditional)
- Applicant: Alaris Medical Systems, Inc.
- Decided: Dec 19, 2002 after 80 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 7 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K940147 (1994). 7 ancestors in all.
21 later devices descend from it; 4 cite it directly.
7 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974332: Variable Pressure Syringe Pump, Alaris Medical Systems, Inc. (1998) Summary page 2.
- K982640: Medex 3000 Series Syringe Infusion Pump, Medex, Inc. (1999) Summary page 2.

## Most influential descendants
- K053554: Compuflo (2006), 6 descendants of its own
- K101194: Navigator Delivery System (or Navigator DS) Model: Nav-010 (2011), 5 descendants of its own
- K112067: Navigator Delivery System (Navigator DS) (2011), 4 descendants of its own
- K111386: Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported Syringes (PSS) (2011), 4 descendants of its own
- K062699: Perfusor Space Infusion Syringe Pump System (2006), 4 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
- Nov 17, 2017 · Class II · Z-0322-2018: The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
- Aug 8, 2016 · Class II · Z-2879-2016: A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.
- Jul 21, 2015 · Class I · Z-2362-2015: Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is unresponsive to key presses until t
- 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 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 Syringe Pump is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of fluids, medications, blood and blood products. The MEDLEY Syringe Pump is indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.

Source page: https://510kreport.com/device/K023264
Methodology: https://510kreport.com/methodology