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BD U-500 Insulin Syringe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151870

by Becton, Dickinson and Company

Identifiers

510(k) Number
K151870 FDA 510(k)
FDA Product Code
FMF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5860 FDA 510(k)
Regulation Number
880.5860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BD U-500 Insulin Syringe is a medical device classified as a syringe for insulin administration, designed specifically for subcutaneous injection of U-500 insulin. It is engineered to accommodate higher insulin concentrations, ensuring precise dosing for patients requiring more than 200 units per day. The syringe’s construction and calibration align with the unique viscosity of U-500 insulin formulations, reducing dosing errors and improving patient safety.

This device is supplied as a single-use, non-sterile syringe intended for clinical use in hospital or home healthcare settings. It is not intended for MRI environments and must be handled with sterile technique prior to administration. The syringe is packaged with color-coded components to match U-500 insulin vial labeling, aiding in proper identification and reducing confusion. Authorized for commercial distribution in the United States under FDA 510(k) clearance (K151870), it adheres to regulatory standards for insulin delivery systems.

Frequently asked questions

What is the BD U-500 Insulin Syringe specifically designed for, and why is it different from standard insulin syringes?

The BD U-500 Insulin Syringe is engineered to administer U-500 insulin, a higher-concentration formulation requiring more than 200 units per day. Unlike standard syringes, it accounts for the thicker viscosity of U-500 insulin, reducing dosing errors and ensuring accurate delivery. Its calibration and construction are tailored to this specific insulin type, improving safety for patients who need these concentrated doses.

Is the BD U-500 Insulin Syringe sterile, and how should it be prepared for use?

The syringe is non-sterile as supplied, meaning it must be handled with sterile technique before administration to ensure patient safety. This includes cleaning the components and preparing the injection site properly, as it is intended for single-use in clinical or home healthcare settings where aseptic practices are standard.

How does the syringe help prevent dosing errors when administering U-500 insulin?

The syringe features color-coded components that align with the labeling of U-500 insulin vials, minimizing confusion between different insulin concentrations. Its precise calibration and design specifically address the higher viscosity of U-500 insulin, reducing the risk of inaccurate dosing—critical for patients requiring concentrated formulations.

Can this syringe be reused, and what are the storage requirements?

The BD U-500 Insulin Syringe is intended for single-use only, per its design and regulatory classification. Storage instructions are not explicitly detailed in the provided data, but as a general guideline for syringes, it should be kept in a cool, dry place away from direct sunlight until use. Always follow manufacturer recommendations for unopened packaging to maintain integrity.

What regulatory pathway was followed for the FDA clearance of this device, and where is it commercially available?

The syringe received FDA 510(k) clearance (K151870) under the Traditional pathway, determined to be *substantially equivalent* to a predicate device. It is authorized for commercial distribution in the United States, adhering to regulatory standards for insulin delivery systems. The clearance was reviewed by the General Hospital (HO) Advisory Committee and filed under product code FMF.

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 Launches First Syringe Designed for Use with Humulin, BD U-500 INSULIN SYRINGE by BECTON, DICKINSON AND COMPANY | FDA 510 (k ..., Becton, Dickinson and Company Receives FDA Clearance for New Syringe ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (1)

  • FDA 510(k) K151870 24 fields · synced Sep 18, 2026