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BD Insulin Syringe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K190054

by Becton, Dickinson and Company

Identifiers

510(k) Number
K190054 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 Insulin Syringe is a hypodermic syringe designed for subcutaneous administration of insulin. It features a precision-engineered needle and graduated markings to ensure accurate dosing, supporting diabetes management in clinical and home-use settings.

Supplied as a single-use, sterile device, the BD Insulin Syringe is intended for use in general hospital environments. It adheres to FDA 510(k) clearance (K190054) under the product code FMF, with a 31-gauge needle and 5/16-inch length for optimal subcutaneous delivery. Storage requires protection from contamination and extreme temperatures.

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® Conventional Needles and Syringes | BD, Bd (Becton Dickinson) - Diabetes Supply Store, BD (company) - Wikipedia, Becton Dickinson | Diabetes Supply Store, Becton Dickinson – Wikipedia

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) K190054 24 fields · synced Oct 6, 2026