Cleared Special

K251654 - BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter

K251654 is an FDA 510(k) clearance for BD Insyte Autoguard Shielded 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 Special 510(k) pathway after a 28-day FDA review.

K251654 · Becton Dickinson Infusion Therapy Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
28d
Days
Class 2
Risk

K251654 is an FDA 510(k) clearance for the BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded.... 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 27, 2025 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K251654

510(k) Number K251654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2025
Decision Date June 27, 2025
Days to Decision 28 days
Submission Type Special
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
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 507
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K251654.
BD Saf-T-Intima™ Subcutaneous Catheter System
K251422 · Becton Dickinson Infusion Therapy Systems, Inc. · Oct 2025
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 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. · Jun 2025
Ruby Intravascular Catheter
K243105 · Venocare, Inc. · May 2025
OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
K250292 · Skydance Vascular, Inc. · May 2025
K251654 · BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter
Download PDF FDA Summary Becton Dickinson Infu…