Cleared Traditional

K250682 - BD Nexiva Diffusics Closed IV Catheter ...

K250682 is an FDA 510(k) clearance for BD Nexiva Diffusics Closed IV Catheter ..., manufactured by Becton Dickinson Infusion Therapy Systems, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K250682 · Becton Dickinson Infusion Therapy Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
89d
Days
Class 2
Risk

K250682 is an FDA 510(k) clearance for the BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Clo.... Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on June 3, 2025 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Becton Dickinson Infusion Therapy Systems, Inc. devices

FDA 510(k) Submission Details - K250682

510(k) Number K250682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 129d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 299
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K250682.
BD Nexiva™ Closed IV Catheter System
K243403 · Becton Dickinson Infusion Therapy Systems, Inc. · Jul 2025
BD Cathena™ Safety IV Catheter
K251155 · Becton Dickinson Infusion Therapy Systems, Inc. · Jul 2025
BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter
K251654 · Becton Dickinson Infusion Therapy Systems, Inc. · Jun 2025
Ruby Intravascular Catheter
K243105 · Venocare, Inc. · May 2025
OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
K250292 · Skydance Vascular, Inc. · May 2025
HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102)
K244059 · Access Vascular, Inc. · Mar 2025