# K072603: Abc Syringe Infusion Pump, Model 4100

- Pathway: 510(k) (Traditional)
- Applicant: Elixir Corporation
- Decided: Oct 23, 2008 after 405 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K890120 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982640: Medex 3000 Series Syringe Infusion Pump, Medex, Inc. (1999) Summary page 1.
- K040899: Medex 3000 Series MR Syringe Infusion Pump, Medex, Inc. (2004) Summary page 1.
- K890120: Syringe Infusion Pump, Medfusion, Inc. (1989) Summary page 1.
- K901755: Model 3001 Syringe Infusion Pump, Medfusion, Inc. (1990). Our reading of the summary gave K091755, which is not a number in FDA’s lists. Corrected to the only number with two digits swapped in this product code whose FDA name shares the summary’s words.
- K955231: Medfusion Model 2001 Syringe Infusion Pump, Medex, Inc. (1996) Summary page 1.

## Indications for use
In any area such as neonatal and pediatric intensive care, anesthesia, adult critical care or any other area where the pump use can be monitored or supervised by a trained healthcare professional where the precise administration of fluids including drugs, antibiotics, lipids, blood, blood products, enteral solutions, or other therapeutic solutions is required Delivery routes include: Intravenous, arterial, epidural, spinal, enteral, and subcutaneous. Delivery modes include: Continuous, volume/time, mass, body weight, and bolus.

Source page: https://510kreport.com/device/K072603
Methodology: https://510kreport.com/methodology