BD Intelliport System
by Becton, Dickinson and Company
510(k) K182092
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182092 | Date30 Apr 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PHC
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The BD Intelliport System is an infusion safety management software designed to enhance medication administration in hospital settings. It integrates with intravenous (IV) infusion pumps and manual IV bolus injection processes to improve workflow efficiency, reduce errors, and support compliance with medication safety protocols. The system is categorized under infusion safety management software and is intended for use in general hospital environments.
The BD Intelliport System is supplied as a software solution and is intended for use in clinical settings where IV medication administration occurs. It is not described as single-use or reusable, nor is there mention of sterility requirements. The system operates within the constraints of FDA-cleared infusion safety management software, adhering to regulatory standards for hospital use. No specific MRI safety or physical size details are provided in the available data.
From the manufacturer
FRANKLIN LAKES, N.J., Jan. 7, 2015 /PRNewswire/ -- BD Medical, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the BD™ Intelliport® Medication Management System, the first-of-its-kind medication management solution for manual IV bolus injections.
FRANKLIN LAKES, N.J., Jan. 7, 2015 / PRNewswire / -- BD Medical, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the BD (TM) Intelliport® Medication Management System, the first-of-its-kind medication management solution for manual IV bolus injections.
Other devices from Becton, Dickinson and Company
Questions
AI-generated answers, 20 Sep 2026
What types of clinical environments is the BD Intelliport System designed to support within a hospital setting?
The BD Intelliport System is specifically designed for general hospital environments where intravenous (IV) medication administration occurs. It integrates with IV infusion pumps and manual IV bolus injection processes to enhance workflow efficiency, reduce errors, and support compliance with medication safety protocols.
How is the BD Intelliport System supplied, and does it require any special handling or storage conditions?
The BD Intelliport System is supplied exclusively as a software solution, meaning it does not involve physical hardware or consumables like single-use components. Since it is software-based, no sterility requirements or special handling (such as single-use or reuse) apply. However, it should be installed and maintained according to the manufacturer’s guidelines to ensure optimal performance and compliance with hospital IT policies.
Is the BD Intelliport System compatible with all types of IV infusion pumps, or does it require specific integration?
The BD Intelliport System is designed to integrate with IV infusion pumps, but the exact compatibility depends on the manufacturer’s integration protocols. While the system is intended for use with infusion pumps in general hospital settings, you should verify compatibility with your existing pump models through Becton, Dickinson and Company’s technical support or documentation.
What regulatory pathway was followed for the BD Intelliport System’s clearance, and how does this affect its use in hospitals?
The BD Intelliport System underwent a traditional 510(k) clearance process through the FDA, categorized under infusion safety management software. This means it was deemed substantially equivalent to a predicate device already on the market, ensuring it meets regulatory standards for safety and effectiveness in hospital environments. Hospitals can rely on this clearance to confirm the system’s compliance with FDA requirements for infusion safety management.
Are there any limitations or special considerations for using the BD Intelliport System in hospitals with diverse IV administration workflows?
The system is tailored for general hospital environments and supports both automated IV infusion pumps and manual IV bolus injection processes. However, its effectiveness may depend on how well it aligns with your hospital’s specific workflows, IT infrastructure, and existing medication safety protocols. Consulting Becton, Dickinson and Company’s implementation guidelines or a clinical specialist can help ensure seamless integration with your current systems.