# K242390: Novum IQ Syringe Pump (40800BAXUS)

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corporation
- Decided: Sep 5, 2024 after 24 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K940147 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
5 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211125: Novum IQ Syringe Pump, Baxter Healthcare Corporation (2022) Summary page 5.

## Recalls of this device
- Aug 11, 2026 · Class II · Z-3065-2026: A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
- Aug 11, 2026 · Class II · Z-3066-2026: A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
- Aug 4, 2025 · Class I · Z-2333-2025: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blan
- May 12, 2025 · Class II · Z-1964-2025: Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on t
- Mar 3, 2025 · Class II · Z-1423-2025: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fl

## Indications for use
The Novum I1Q 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 1Q Syringe Pump is intended to deliver an infusion through the following clinically accepted routes of administration: intravenous, arterial, enteral and subcutaneous. The Novum 1Q 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 I1Q Syringe Pump is suitable for patient care in hospitals and outpatient health care facilities. The Novum 1Q Syringe Pump is intended for use on adults, pediatrics and neonates. The Novum I1Q 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 1Q Syringe Pump is intended to be used by trained healthcare professionals.

Source page: https://510kreport.com/device/K242390
Methodology: https://510kreport.com/methodology