# K233529: BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector

- Pathway: 510(k) (Special)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Dec 1, 2023 after 29 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: 7 generations back to K032843 (2004). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 5.

## Most influential descendants
- K250682: BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (2025), 0 descendants of its own

## Indications for use
The BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient’s vascular system for short term use to sample blood or administer fluids. These devices 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. These devices are 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/K233529
Methodology: https://510kreport.com/methodology