# K230022: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Mar 31, 2023 after 86 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 5 (2 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.
1 later device descends from it; 1 cites it directly.
5 of 11 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
- K251640: SIGMA Spectrum Infusion Pump with Master Drug Library (2025), 0 descendants of its own

## Recalls of this device
- Jun 20, 2025 · Class I · Z-2096-2025: Certain Spectrum infusion pumps may have an incorrect version of software.
- Nov 19, 2024 · Class II · Z-0776-2025: Devices were identified as released after repair without full testing being performed, which includes flow testing.
- Jul 17, 2024 · Class II · Z-2581-2024: 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
- Jun 14, 2024 · Class II · Z-2530-2024: Improperly performed testing prior to release
- Jun 15, 2023 · Class I · Z-2103-2023: 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 Baxter 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, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes; intravenous, arterial, subcutaneous, epidural or irrigation of fluid space. The Baxter 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 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient care environments such as, but not limited to hospitals and outpatient care areas. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming, thereby helping to reduce errors. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used by trained healthcare professionals.

Source page: https://510kreport.com/device/K230022
Methodology: https://510kreport.com/methodology