# K230041: Spectrum IQ Infusion System with Dose IQ Safety Software

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Mar 31, 2023 after 84 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 7 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904518 (1990). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222048: Spectrum IQ Infusion System with Dose IQ Safety Software, Baxter Healthcare Corporation (2022) Summary page 5.

## Most influential descendants
- K251636: Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (2025), 0 descendants of its own

## Recalls of this device
- Jul 14, 2025 · Class II · Z-2415-2025: Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the de
- Feb 5, 2025 · Class I · Z-1254-2025: There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
- Oct 2, 2024 · Class II · Z-0348-2025: The door on the Spectrum IQ Infusion pump may not be able to fully close.
- Jul 17, 2024 · Class II · Z-2582-2024: The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 o
- Apr 9, 2024 · Class II · Z-1810-2024: There is a potential for cracks on the mount of the front panel of the device.
- Mar 20, 2024 · Class II · Z-1775-2024: One device was improperly performed testing prior to release from a Service Center.
- Jun 15, 2023 · Class I · Z-2104-2023: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported 

## Indications for use
The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, and blood products. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, or epidural. The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user. The Spectrum IQ Infusion System with Dose IQ Safety Software is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas. The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to reduce operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies. This automation is intended to reduce pump programming errors and increase accuracy of infusion documentation. The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used by trained healthcare professionals.

Source page: https://510kreport.com/device/K230041
Methodology: https://510kreport.com/methodology