# K173084: Spectrum IQ Infusion System, Dose IQ Safety Software

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: May 11, 2018 after 224 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 8 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904518 (1990). 9 ancestors in all.
9 later devices descend from it; 5 cite it directly.
8 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133801: Baxter Sigma Spectrum Infusion Pump with Master Drug Library, Baxter Healthcare Corporation (2014) Summary page 5.

## Most influential descendants
- K220417: Spectrum IQ Infusion System with Dose IQ Safety Software (2022), 3 descendants of its own
- K222048: Spectrum IQ Infusion System with Dose IQ Safety Software (2022), 2 descendants of its own
- K230041: Spectrum IQ Infusion System with Dose IQ Safety Software (2023), 1 descendant of its own
- K183311: Ivenix Infusion System (IIS) (2019), 1 descendant of its own
- K251636: Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (2025), 0 descendants of its own

## Recalls of this device
- Dec 29, 2021 · Class I · Z-0529-2022: There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomp
- Jul 7, 2021 · Class I · Z-2165-2021: Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump.
- Jun 4, 2021 · Class I · Z-2110-2021: System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectru
- Mar 19, 2021 · Class II · Z-1487-2021: Potentially defective component in the AC power adapter which may fail over time.
- Jan 6, 2021 · Class II · Z-1150-2021: Battery performance issues related to prolonged storage.
- Nov 23, 2020 · Class II · Z-0715-2021: There is a potential software error during programming.
- Jun 30, 2020 · Class I · Z-0123-2021: Baxter is updating the device IFU for safety communication regarding cleaning practices.
- Sep 18, 2018 · Class II · Z-0107-2019: If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error,

## 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. 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/K173084
Methodology: https://510kreport.com/methodology