# K211125: Novum IQ Syringe Pump

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Aug 30, 2022 after 502 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K940147 (1994). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111386: Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported Syringes (PSS), Smiths Medical MD, Inc. (2011) Summary page 5.

## Most influential descendants
- K242390: Novum IQ Syringe Pump (40800BAXUS) (2024), 0 descendants of its own

## Recalls of this device
- Oct 13, 2023 · Class I · Z-0151-2024: Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm 

## Indications for use
The Novum IQ Syringe Pump is intended to be used for the controlled administration of fluids. These include pharmaceutical drugs, parenteral nutrition, blood and blood products, and enteral nutrition. The Novum IQ Syringe Pump is intended to deliver an infusion through the following clinically accepted routes of administration: intravenous, arterial, enteral and subcutaneous. The Novum IQ Syringe Pump is intended to be used in conjunction with legally marketed and compatible administration sets, syringes, and medications provided by the user. The Novum IQ Syringe Pump is suitable for patient care in hospitals and outpatient health care facilities. The Novum IQ Syringe Pump is intended for use on adults, pediatrics and neonates. The Novum IQ Syringe Pump is intended to aid in the reduction of operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies when integrated with an Electronic Medical Record (EMR) system. This automation is intended to aid in the reduction of programming errors. The Novum IQ Syringe Pump is intended to be used by trained healthcare professionals.

Source page: https://510kreport.com/device/K211125
Methodology: https://510kreport.com/methodology