Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SIGMA Spectrum Infusion Pump with Master Drug Library

K-Number: K251640 · 2025-07-28

ApplicantBaxter Healthcare Corporation
Decision Date2025-07-28
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SIGMA Spectrum Infusion Pump with Master Drug Library is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2025-07-28 under 510(k) number K251640. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA Spectrum Infusion Pump with Master Drug Library?

SIGMA Spectrum Infusion Pump with Master Drug Library is a medical device that received FDA 510(k) clearance on 2025-07-28. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K251640.

When did SIGMA Spectrum Infusion Pump with Master Drug Library receive FDA 510(k) clearance?

SIGMA Spectrum Infusion Pump with Master Drug Library received FDA 510(k) clearance on 2025-07-28, under 510(k) number K251640.

Who is the listed applicant for SIGMA Spectrum Infusion Pump with Master Drug Library?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGMA Spectrum Infusion Pump with Master Drug Library?

The FDA product code for SIGMA Spectrum Infusion Pump with Master Drug Library is FRN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03366155Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the LiverCOMPLETEDNCT03856658Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver MetastasesACTIVE_NOT_RECRUITINGNCT05286814PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical CarcinomaRECRUITING

Other records listing Baxter Healthcare Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P210036Agent, absorbable hemostatic, non-collagen basedK251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)PMA P990009Absorbable collagen hemostatic agent with thrombinK251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)PMA P100030Sealant, polymerizingK243529Solution Administration Sets

View all 53 devices →

Related Devices (Code: FRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.K242115Plum Duo™ Precision IV PumpIcu Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑