Cleared Traditional

BD Alaris Infusion System with Guardrails Suite MX

K243855 · Carefusion 303, Inc. · General Hospital
Apr 2025
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K243855 is an FDA 510(k) clearance for the BD Alaris Infusion System with Guardrails Suite MX, 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 April 25, 2025, 130 days after receiving the submission on December 16, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K243855 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2024
Decision Date April 25, 2025
Days to Decision 130 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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