# K161777: BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Aug 29, 2016 after 61 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K032843 (2004). 5 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102520: BD Nexiva Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2011) Summary page 5.
- K123734: BD Nexiva Diffusics Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2013) Summary page 5.

## Most influential descendants
- K170336: BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector (2017), 6 descendants of its own
- K183399: BD Nexiva Closed IV Catheter System (2019), 5 descendants of its own
- K170283: BD Nexiva Diffusics Closed IV Catheter System (2017), 3 descendants of its own
- K173354: BD Nexiva Diffusics Closed IV Catheter Systems (2017), 2 descendants of its own
- K243403: BD Nexiva™ Closed IV Catheter System (2025), 1 descendant of its own

## Recalls of this device
- Mar 1, 2019 · Class II · Z-1710-2019: Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.

## Indications for use
BD Nexiva closed IV catheter systems 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 22-18GA (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. BD Nexiva Diffusics closed IV catheter systems 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 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/K161777
Methodology: https://510kreport.com/methodology