# K251640: SIGMA Spectrum Infusion Pump with Master Drug Library

- 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: 6 generations back to K904518 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
5 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230022: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Baxter Healthcare Corporation (2023) Summary page 5.

## Recalls of this device
- Nov 28, 2025 · Class II · Z-1121-2026: Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insuffi

## 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, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, or epidural. 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 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 SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming, thereby helping to reduce errors. The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used by trained healthcare professionals.

Source page: https://510kreport.com/device/K251640
Methodology: https://510kreport.com/methodology