# K183399: BD Nexiva Closed IV Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Mar 20, 2019 after 103 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K942988 (1995). 21 ancestors in all.
5 later devices descend from it; 4 cite 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)
- K170336: BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector, Becton, Dickinson and Company (2017) Summary page 4.
- K161777: BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems, Becton Dickinson Infusion Therapy Systems, Inc. (2016) Summary page 4.

## Most influential descendants
- 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
- K202060: Disposable IV catheter (2021), 0 descendants of its own

## Recalls of this device
- Oct 12, 2022 · Class II · Z-0174-2023: During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).
- Sep 8, 2021 · Class II · Z-0306-2022: There is a breach in the product packaging that renders the product non-sterile.
- Sep 14, 2020 · Class II · Z-0125-2021: Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted

## Indications for use
BD Nexiva closed IV catheter systems are intended to be inserted into a patient’s peripheral 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. 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/K183399
Methodology: https://510kreport.com/methodology