# K222048: Spectrum IQ Infusion System with Dose IQ Safety Software

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Sep 6, 2022 after 56 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K904518 (1990). 11 ancestors in all.
2 later devices descend 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)
- K220417: Spectrum IQ Infusion System with Dose IQ Safety Software, Baxter Healthcare Corporation (2022) Summary page 5.

## Most influential descendants
- K230041: Spectrum IQ Infusion System with Dose IQ Safety Software (2023), 1 descendant of its own
- K251636: Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (2025), 0 descendants of its own

## Indications for use
The SIGMA Spectrum Infusion Pump with Master Drug Library 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, epidural or irrigation of fluid space. The SIGMA Spectrum Infusion Pump with Master Drug Library 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/K222048
Methodology: https://510kreport.com/methodology