Cleared Traditional

BD Nexiva? Diffusics? Closed IV Catheter System and BD Nexiva? Diffusics? Closed IV Catheter System with BD MaxZero? Needle-free Connector

K250682 · Becton Dickinson Infusion Therapy Systems, Inc. · General Hospital

Jun 2025

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K250682 is an FDA 510(k) clearance for the BD Nexiva? Diffusics? Closed IV Catheter System and BD Nexiva? Diffusics? Closed IV Catheter System with BD MaxZero? Needle-free Connector, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on June 3, 2025, 89 days after receiving the submission on March 6, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K250682 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2025
Decision Date	June 03, 2025
Days to Decision	89 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200