BD Intelliport System
FDA 510(k) K182092 · Becton, Dickinson and Company
510(k) numberK182092
Submission
- Device name
- BD Intelliport System
- Applicant
- Becton, Dickinson and Company
Franklin Lakes, NJ, US - Received
- August 3, 2018
- Decision date
- April 30, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PHC – Infusion Safety Management Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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.
Other 510(k)s with product code PHC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252130 | LifeShield Infusion Safety Software SuitePHC · Traditional | Icu Medical, Inc. | 04/02/2026SE |
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229)…PHC · Traditional | Becton Dickinson | 06/20/2025SE |
| K242117 | LifeShield Infusion Safety Software SuitePHC · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K230665 | Dose IQ Safety SoftwarePHC · Traditional | Baxter Healthcare Corporation | 03/29/2024SE |
| K223606 | LifeShield Infusion Safety Software SuitePHC · Traditional | Icu Medical, Inc. | 08/24/2023SE |
| K211124 | Dose IQ Safety SoftwarePHC · Traditional | Baxter Healthcare Corporation | 08/30/2022SE |
| K210075 | Vigilant Software Suite Vigilant Master MedPHC · Traditional | Fresenius Kabi AG | 03/01/2022SE |
| K141474 | Becton Dickinson Intelliport SystemPHC · Traditional | Becton, Dickinson & CO | 12/18/2014SE |
| K141193 | Medfusion 4000 Pump Device Specific Reports Solfware for Pharmguard Server Version 2.0PHC · Traditional | Smiths Medical Asd, Inc. | 07/25/2014SE |
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Questions and answers
When was BD Intelliport System cleared by the FDA?
BD Intelliport System (K182092) received a 510(k) decision of Substantially Equivalent on April 30, 2019, 270 days after the submission was received.
What is the product code of K182092?
The FDA product code is PHC – Infusion Safety Management Software, a Class II (moderate risk) device regulated under 21 CFR 880.5725.