# K170336: BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Mar 10, 2017 after 36 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: 6 generations back to K942988 (1995). 20 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161777: BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems, Becton Dickinson Infusion Therapy Systems, Inc. (2016) Summary page 4.
- K132413: MZ1000, Care Fusion (2013) Summary page 4.

## Most influential descendants
- K183399: BD Nexiva Closed IV Catheter System (2019), 5 descendants of its own
- K243403: BD Nexiva™ Closed IV Catheter System (2025), 1 descendant of its own
- K261041: ClearSafe Closed System (2026), 0 descendants of its own
- K232234: Nouvo Safety Set (2024), 0 descendants of its own
- K231239: Nexiva™ Closed IV Catheter System with NearPort™ IV Access (2023), 0 descendants of its own

## Indications for use
BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector devices are intended to be inserted into a patient’s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters 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 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.

Source page: https://510kreport.com/device/K170336
Methodology: https://510kreport.com/methodology