Cleared Special

K251654 - BD Insyte Autoguard Shielded IV Catheter

K251654 is the FDA 510(k) clearance for BD Insyte Autoguard Shielded IV Catheter by Becton Dickinson Infusion Therapy Systems, Inc.. It is a Class 2 General Hospital device (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
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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.

View all Becton Dickinson Infusion Therapy Systems, Inc. devices

Submission Details

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.

Device Classification

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 240
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K251654.
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K250682 · Becton Dickinson Infusion Therapy Systems, Inc. · Jun 2025
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K250292 · Skydance Vascular, Inc. · May 2025