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Novum IQ Syringe Pump

by Baxter Healthcare Corporation 510(k)

Active United States

510(k) K211125

Overview

The Novum IQ Syringe Pump is an infusion pump device designed for the controlled administration of fluids to patients. It is part of the Novum IQ platform, which includes safety features and interoperability across Large Volume and Syringe pumps, with streamlined EMR integration and drug library compliance.

The device is supplied as a pump with battery and power cord. It is intended for use in general hospital settings and has received FDA 510(k) clearance with the product code FRN. The device is classified as Class 2 and is regulated under number 880.5725.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211125 Date30 Aug 2022ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0151-2024 FDA Class I initiated 13 Oct 2023

    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 even though uninfused fluid remains in the syringe.

Specification

510(k)

510(k) Number
FDA Product Code
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Baxter Healthcare Corporation

See all devices from Baxter Healthcare Corporation →

Questions

  • What is the Novum IQ Syringe Pump used for?

    The Novum IQ Syringe Pump is designed for the controlled administration of fluids to patients in general hospital settings. It is part of the Novum IQ platform, which includes safety features and interoperability across Large Volume and Syringe pumps.

  • How is the Novum IQ Syringe Pump supplied?

    The device is supplied as a pump with battery and power cord. It is intended for use in general hospital settings and has received FDA 510(k) clearance with the product code FRN.

  • What regulatory approvals does the Novum IQ Syringe Pump have?

    The Novum IQ Syringe Pump has received FDA 510(k) clearance with the product code FRN. It is classified as Class 2 and is regulated under number 880.5725.

  • What are the key features of the Novum IQ Syringe Pump?

    The Novum IQ Syringe Pump includes safety features and interoperability across Large Volume and Syringe pumps, with streamlined EMR integration and drug library compliance.