# K211122: Novum IQ Large Volume Pump

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Mar 29, 2024 after 1,079 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K904518 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
6 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173084: Spectrum IQ Infusion System, Dose IQ Safety Software, Baxter Healthcare Corporation (2018) Summary page 5.

## Recalls of this device
- Aug 4, 2025 · Class I · Z-2332-2025: 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
- Jul 14, 2025 · Class I · Z-2173-2025: Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is 
- Apr 24, 2025 · Class I · Z-1767-2025: There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.

## Indications for use
The Novum IQ Large Volume Pump (LVP) is intended for use on adults and pediatric subpopulations, except for neonates, for the controlled administration of fluids, pharmaceutical drugs, parenteral nutrition, blood and blood products through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous and epidural. The Novum IQ LVP is intended for use on neonates, for the controlled administration of fluids and parenteral nutrition through the following clinically accepted routes of administration: intravenous and arterial. The Novum IQ LVP is intended to be used in conjunction with legally marketed and compatible administration sets, and medications provided by the user. The Novum IQ LVP is suitable for patient care in hospitals and outpatient health care facilities. The Novum IQ LVP 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 LVP is intended to be used by trained healthcare professionals.

Source page: https://510kreport.com/device/K211122
Methodology: https://510kreport.com/methodology