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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 the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 303, Inc.. It received FDA 510(k) clearance on 2023-07-21 under 510(k) 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. The listed applicant is Carefusion 303, Inc.. The 510(k) number is K211218.

When did BD Alaris System with Guardrails Suite MX v12.1.2 receive FDA 510(k) clearance?

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

Who is the listed applicant for BD Alaris System with Guardrails Suite MX v12.1.2?

The FDA 510(k) record lists Carefusion 303, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Carefusion 303, Inc. 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.

K243855BD Alaris Infusion System with Guardrails Suite MXK171957MaxZero Extension Sets with Needless ConnectorK163316Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System

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.K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK251636Spectrum 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.

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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