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FDA 510(k)

BD Alaris Infusion System with Guardrails Suite MX

K-Number: K243855 · 2025-04-25

ApplicantCarefusion 303, Inc.
Decision Date2025-04-25
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Alaris Infusion System with Guardrails Suite MX is a medical device manufactured by Carefusion 303, Inc.. It received FDA 510(k) clearance on 2025-04-25 under approval number K243855. 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 BD Alaris Infusion System with Guardrails Suite MX?

BD Alaris Infusion System with Guardrails Suite MX is a medical device that received FDA 510(k) clearance on 2025-04-25. It is manufactured by Carefusion 303, Inc.. The 510(k) number is K243855.

When was BD Alaris Infusion System with Guardrails Suite MX approved by the FDA?

BD Alaris Infusion System with Guardrails Suite MX received FDA 510(k) clearance on 2025-04-25, under approval number K243855.

What company makes BD Alaris Infusion System with Guardrails Suite MX?

BD Alaris Infusion System with Guardrails Suite MX is manufactured by Carefusion 303, Inc..

What is the FDA product code for BD Alaris Infusion System with Guardrails Suite MX?

The FDA product code for BD Alaris Infusion System with Guardrails Suite MX is FRN.

Related Clinical Trials

NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT07575191 Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer NOT_YET_RECRUITING NCT05286814 PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma RECRUITING NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING NCT02812927 Evaluation of Glycemic Variability (GLAIVE) COMPLETED NCT01384513 A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies COMPLETED

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Carefusion 303, Inc.

K171957MaxZero Extension Sets with Needless Connector K163316Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System K211218BD Alaris System with Guardrails Suite MX v12.1.2

Related Devices (Code: FRN)

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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.

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