# K141474: Becton Dickinson Intelliport System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Dec 18, 2014 after 198 days
- Product code: PHC (Infusion Safety Management Software)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K904518 (1990). 10 ancestors in all.
2 later devices descend 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)
- K062388: Anesthesia Information and Digital-Drug Management System, Docusys (2007) Summary page 5.

## Most influential descendants
- K182092: BD Intelliport System (2019), 1 descendant of its own
- 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

## Recalls of this device
- Dec 9, 2015 · Class II · Z-1076-2016: The sterility of the product cannot be assured. This may result in increased risk of infection.

## 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 areas. 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.

Source page: https://510kreport.com/device/K141474
Methodology: https://510kreport.com/methodology