Cleared Traditional

BD Intelliport System

K182092 · Becton, Dickinson and Company · General Hospital

Apr 2019

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K182092 is an FDA 510(k) clearance for the BD Intelliport System, a Infusion Safety Management Software (Class II — Special Controls, product code PHC), submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on April 30, 2019, 270 days after receiving the submission on August 3, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K182092 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 2018
Decision Date	April 30, 2019
Days to Decision	270 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.