Cleared Traditional

BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)

K243062 · Becton Dickinson · General Hospital

Jun 2025

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K243062 is an FDA 510(k) clearance for the BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231), a Infusion Safety Management Software (Class II — Special Controls, product code PHC), submitted by Becton Dickinson (Franklin Lakes, US). The FDA issued a Cleared decision on June 20, 2025, 266 days after receiving the submission on September 27, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K243062 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2024
Decision Date	June 20, 2025
Days to Decision	266 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PHC — Infusion Safety Management Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5725
Definition	Infusion Safety Management Software Is A Prescription Device Intended For Use With Infusion Pumps And May Include One Or More Of The Following Capabilities: Prepopulation Of Infusion Programming Parameters, Data Retrieval And Analysis For Tracking And Trending, Drug Infusion Error Reduction Algorithms, And Alarm Transmission.