# K243062: BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson
- Decided: Jun 20, 2025 after 266 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: 8 generations back to K904518 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182092: BD Intelliport System, Becton, Dickinson and Company (2019) Summary page 5.

## Indications for use
The BD Intelliport TM 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 TM System allows the clinician to record anesthesia-related medication administration events during pre-procedure, intra-procedure and recovery phase. 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 TM System is intended for patients with body weights >20 kg. Do not use the BD Intelliport TM System with blood, blood products, biologics, or chemotherapeutics.

Source page: https://510kreport.com/device/K243062
Methodology: https://510kreport.com/methodology