# K982640: Medex 3000 Series Syringe Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Medex, Inc.
- Decided: Apr 6, 1999 after 251 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890120 (1989). 4 ancestors in all.
23 later devices descend from it; 2 cite it directly.
7 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890120: Syringe Infusion Pump, Medfusion, Inc. (1989) Summary page 1.
- K901755: Model 3001 Syringe Infusion Pump, Medfusion, Inc. (1990) Summary page 1.
- K955231: Medfusion Model 2001 Syringe Infusion Pump, Medex, Inc. (1996) Summary page 1.
- K945942: Auto Syringe (R) AS50 Infusion Pump, Baxter Healthcare Corp (1995) Summary page 1.

## Most influential descendants
- K023264: Medley Syringe Pump Module System, Model 8110 (2002), 21 descendants of its own
- 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

## Recalls of this device
- Feb 3, 2007 · Not classified · Z-0768-2007: Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump's startup sequence when the pump's Preventative Maintenance Alarm goes off, pre

## Indications for use
The Medex 3000 Series Syringe Infusion Pump indications for use are as follows: ¢ in the administration of fluids requiring precisely controlled infusion rates including blood or bfood products, lipids, drugs, antibiotics and other therapeutic fluids. ¢ in the following delivery routes: arterial, epidural, intravenous, spinal, and subcutaneous. ¢ in the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus. « in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the Syringe Infusion Pump can be monitored or supervised by a clinician. ¢ the Syringe Infusion Pump is contraindicated for use on the inlet side of extracorporeal membrane oxygenation (ECMO) systems where high negative pressures may occur.

Source page: https://510kreport.com/device/K982640
Methodology: https://510kreport.com/methodology