← Back to catalogue

BD Insyte IV Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252137

by Becton Dickinson Infusion Therapy Systems Inc.

Identifiers

510(k) Number
K252137 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 BD Insyte IV Catheter is a shielded intravenous catheter made of BD Vialon biomaterial with a standard-vein, notched needle. It is designed for intravenous infusion procedures and features a needle that instantly retracts when activated, reducing the risk of needlestick injuries.

The catheter is available in various sizes including 18 G x 1.16 in. (1.3 mm x 30 mm) and 18 G x 1.88 in. (1.3 mm x 48 mm). It is supplied in cases of 200 units and is intended for single-use. The device has received FDA 510(k) clearance with the product code FOZ and was reviewed by the General Hospital advisory committee.

Frequently asked questions

What is the BD Insyte IV Catheter used for?

The BD Insyte IV Catheter is designed for intravenous infusion procedures. It features a shielded design with a standard-vein, notched needle that instantly retracts when activated, helping to reduce the risk of needlestick injuries during use.

What sizes are available for the BD Insyte IV Catheter?

The BD Insyte IV Catheter is available in various sizes including 18 G x 1.16 in. (1.3 mm x 30 mm) and 18 G x 1.88 in. (1.3 mm x 48 mm) to accommodate different clinical needs and patient requirements.

How is the BD Insyte IV Catheter supplied and is it reusable?

The BD Insyte IV Catheter is supplied in cases of 200 units and is intended for single-use only. It should not be reused on multiple patients as this could compromise sterility and increase infection risks.

What regulatory status does the BD Insyte IV Catheter have?

The BD Insyte IV Catheter has received FDA 510(k) clearance with the product code FOZ. It was reviewed by the General Hospital advisory committee and 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: BECTON DICKINSON INFUSION THERAPY Insyte Autoguard Shielded IV Catheter ..., Becton Dickinson Infusion Therapy 18g 1.88in Bd Autoguard Cath, IV infusion catheter - Insyte™ Autoguard™ BC - BD - MedicalExpo, BD Insyte Autoguard Shielded IV Catheter - Becton Dickinson & Co

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (1)

  • FDA 510(k) K252137 24 fields · synced Sep 26, 2026