Cleared Traditional

BECTON DICKINSON INTELLIPORT SYSTEM

K141474 · Becton, Dickinson & CO · General Hospital

Dec 2014

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K141474 is an FDA 510(k) clearance for the BECTON DICKINSON INTELLIPORT SYSTEM, a Infusion Safety Management Software (Class II — Special Controls, product code PHC), submitted by Becton, Dickinson & CO (San Diego, US). The FDA issued a Cleared decision on December 18, 2014, 198 days after receiving the submission on June 3, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K141474 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2014
Decision Date	December 18, 2014
Days to Decision	198 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.