Cleared Traditional

BD Alaris System with Guardrails Suite MX v12.1.2

K211218 · Carefusion 303, Inc. · General Hospital
Jul 2023
Decision
819d
Days
Class 2
Risk

About This 510(k) Submission

K211218 is an FDA 510(k) clearance for the BD Alaris System with Guardrails Suite MX v12.1.2, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Carefusion 303, Inc. (San Diego, US). The FDA issued a Cleared decision on July 21, 2023, 819 days after receiving the submission on April 23, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K211218 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2021
Decision Date July 21, 2023
Days to Decision 819 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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