Cleared Traditional

K243855 - BD Alaris Infusion System with Guardrai...

K243855 is an FDA 510(k) clearance for BD Alaris Infusion System with Guardrai..., manufactured by Carefusion 303, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K243855 · Carefusion 303, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
130d
Days
Class 2
Risk

K243855 is an FDA 510(k) clearance for the BD Alaris Infusion System with Guardrails Suite MX. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Carefusion 303, Inc. (San Diego, US). The FDA issued a Cleared decision on April 25, 2025 after a review of 130 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Carefusion 303, Inc. devices

FDA 510(k) Submission Details - K243855

510(k) Number K243855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 129d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 459
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K243855.
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
K251636 · Baxter Healthcare Corporation · Jul 2025
SIGMA Spectrum Infusion Pump with Master Drug Library
K251640 · Baxter Healthcare Corporation · Jul 2025
MRidium 3870 MRI Infusion Pump System (3870)
K242752 · Iradimed Corporation · May 2025
Plum Solo™ Precision IV Pump
K242114 · Icu Medical, Inc. · Apr 2025
Plum Duo™ Precision IV Pump
K242115 · Icu Medical, Inc. · Apr 2025
RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
K250357 · Deka Research & Development Corp. · Mar 2025