# K231239: Nexiva™ Closed IV Catheter System with NearPort™ IV Access

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Sep 22, 2023 after 147 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 K942988 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183399: BD Nexiva Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2019) Summary page 4.

## Indications for use
The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is intended to be inserted into a patient's peripheral venous system for short term use to administer fluids and/or medications and to sample blood. 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. The 24-18 GA (0.7-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when connected to the NearPort™ IV Access.

Source page: https://510kreport.com/device/K231239
Methodology: https://510kreport.com/methodology