# K251636: Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Jul 28, 2025 after 60 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K904518 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
6 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230041: Spectrum IQ Infusion System with Dose IQ Safety Software, Baxter Healthcare Corporation (2023) Summary page 5.

## Recalls of this device
- Jan 13, 2026 · Class II · Z-1368-2026: Pumps were released without full testing being performed, including occlusion alarm testing.

## 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/K251636
Methodology: https://510kreport.com/methodology