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FDA 510(k)

BD Alaris System with Guardrails Suite MX v12.1.2

K-Number: K211218 · 2023-07-21

ApplicantCarefusion 303, Inc.
Decision Date2023-07-21
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Alaris System with Guardrails Suite MX v12.1.2 is a medical device manufactured by Carefusion 303, Inc.. It received FDA 510(k) clearance on 2023-07-21 under approval number K211218. 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 System with Guardrails Suite MX v12.1.2?

BD Alaris System with Guardrails Suite MX v12.1.2 is a medical device that received FDA 510(k) clearance on 2023-07-21. It is manufactured by Carefusion 303, Inc.. The 510(k) number is K211218.

When was BD Alaris System with Guardrails Suite MX v12.1.2 approved by the FDA?

BD Alaris System with Guardrails Suite MX v12.1.2 received FDA 510(k) clearance on 2023-07-21, under approval number K211218.

What company makes BD Alaris System with Guardrails Suite MX v12.1.2?

BD Alaris System with Guardrails Suite MX v12.1.2 is manufactured by Carefusion 303, Inc..

What is the FDA product code for BD Alaris System with Guardrails Suite MX v12.1.2?

The FDA product code for BD Alaris System with Guardrails Suite MX v12.1.2 is FRN.

Related Clinical Trials

NCT07263815 EQUIP - Evaluation of Quality of Imaging on a Next-generation Total Body Pet Scan in Comparison to Conventional PET ACTIVE_NOT_RECRUITING

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 K243855BD Alaris Infusion System with Guardrails Suite MX

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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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