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Insyte Catheter, Insyte Autoguard Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K000235

by Becton Dickinson Infusion Therapy Systems Inc.

Identifiers

510(k) Number
K000235 FDA 510(k)
FDA Product Code
FOZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5200 FDA 510(k)
Regulation Number
880.5200 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Insyte Autoguard Catheter is a shielded intravenous catheter designed to provide safety activation with a push of a button, fully encapsulating the needle after activation to reduce the risk of needlestick injury. It features BD Instaflash Needle Technology to confirm immediate vessel entry and improve first-stick success. The catheter is available in multiple sizes, including winged and non-winged variants, and is made of BD Vialon biomaterial.

The device is supplied as a sterile, single-use product and is intended for use in general hospital settings. It is not reusable and does not require specific storage conditions beyond standard medical device storage. The device has received FDA 510(k) clearance as substantially equivalent to predicate devices.

Frequently asked questions

How does the Insyte Autoguard Catheter prevent needlestick injuries?

The device is designed with a safety activation feature that fully encapsulates the needle with a single push of a button, eliminating the exposed needle tip after use.

What is BD Instaflash Needle Technology?

This technology provides an immediate visual flash upon vessel entry, which helps confirm successful placement and improves the likelihood of a successful first attempt.

Is the Insyte Autoguard Catheter reusable?

No, the device is supplied as a sterile, single-use product and is not intended for reuse.

What materials is the catheter made from?

The catheter is constructed from BD Vialon biomaterial, which is a proprietary material designed for improved performance.

What is the regulatory status of this device?

The Insyte Autoguard Catheter has received FDA 510(k) clearance, which indicates it has been determined to be substantially equivalent to predicate devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD Insyte Autoguard™ Shielded IV Catheter, BECTON DICKINSON INFUSION THERAPY Insyte Autoguard Shielded IV Catheter ..., BD Insyte Autoguard Shielded IV Catheter with Blood Control

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
FDA Applicant
Becton Dickinson Infusion Therapy Systems, Inc.

Sources (1)

  • FDA 510(k) K000235 24 fields · synced Sep 26, 2026