# K250682: BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Jun 3, 2025 after 89 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- 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 K032843 (2004). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173354: BD Nexiva Diffusics Closed IV Catheter Systems, Becton Dickinson Infusion Therapy Systems, Inc. (2017) Summary page 6.
- K233529: BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector, Becton Dickinson Infusion Therapy Systems, Inc. (2023) Summary page 6.

## Indications for use
BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure or administer fluids. This device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. This device is suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.

Source page: https://510kreport.com/device/K250682
Methodology: https://510kreport.com/methodology