# K182092: BD Intelliport System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Apr 30, 2019 after 270 days
- Product code: PHC (Infusion Safety Management Software)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K904518 (1990). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141474: Becton Dickinson Intelliport System, Becton, Dickinson & CO (2014) Summary page 4.

## Most influential descendants
- K243062: BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) (2025), 0 descendants of its own

## Indications for use
The BD Intelliport™ system is an automated record keeping system that incorporates patient safety features that are aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables the identification, measurement, alerting and documentation of the administration of medications to patients. The BD Intelliport™ system allows the clinician to record anesthesia-related, medication administration events in the pre-op, intra-op, and PACU. The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications. The BD Intelliport™ system is intended for patients whose body weights are >20kg. The BD Intelliport™ system is not intended for use with blood, blood products, biologics, or chemotherapeutics. The BD Intelliport™ system is not intended for use with refrigerated medications (excluding cefazolin).

Source page: https://510kreport.com/device/K182092
Methodology: https://510kreport.com/methodology