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BD Flu+ Syringe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K203359

by Becton, Dickinson and Company

Identifiers

510(k) Number
K203359 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 Flu+ Syringe is a single-use, pre-filled syringe designed for the aspiration and injection of fluids, including vaccines. It is classified under the product code FMF and is intended for general hospital use, featuring a minimal dead-space design to maximize dose availability.

This device is supplied sterile, intended for single-use only, and has received FDA 510(k) clearance under the Traditional pathway. It is manufactured by Becton, Dickinson and Company and is regulated under the K-number K203359. The syringe is intended for use in clinical settings where precise fluid administration is required, adhering to standard aseptic practices.

Frequently asked questions

What types of fluids can the BD Flu+ Syringe be used for, and why is it designed this way?

The BD Flu+ Syringe is specifically designed for the aspiration and injection of fluids, including vaccines. Its minimal dead-space design ensures that nearly the entire volume of the fluid is available for administration, which is particularly important for vaccines where precise dosing is critical to ensure patient safety and efficacy. This feature helps maximize dose accuracy and reduces waste.

Is the BD Flu+ Syringe reusable, and if not, what are the implications for clinical settings?

No, the BD Flu+ Syringe is intended for single-use only, as explicitly stated in its design. This ensures sterility and reduces the risk of contamination or cross-infection between patients. Clinicians must adhere to this guideline to maintain aseptic practices, especially in hospital settings where precision and safety are paramount. Discarding after use aligns with standard infection control protocols.

How is the BD Flu+ Syringe supplied, and what does that mean for storage and handling?

The BD Flu+ Syringe is supplied sterile and pre-filled, meaning it is ready for immediate use without additional preparation. This requires proper storage in a clean, dry environment to preserve sterility until use. Clinicians should follow manufacturer guidelines for storage conditions (e.g., room temperature, protected from light) to ensure the device remains uncontaminated and functional until deployment.

What regulatory pathway was followed for FDA clearance, and what does that mean for its use in hospitals?

The BD Flu+ Syringe received FDA clearance under the Traditional 510(k) pathway, specifically classified as *Substantially Equivalent* (SESE) to a predicate device. This means it was determined to have the same intended purpose and technological characteristics as a previously cleared product, ensuring it meets regulatory standards for safety and effectiveness. Hospitals can rely on this clearance to confirm its compliance with U.S. medical device regulations for general hospital use.

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® Flu+ Syringe with cannula | BD, BD Flu+ Syringe (K203359) — FDA 510 (k) | Innolitics, Vaccine syringes - BD, BD (company) - Wikipedia, BD FLU+ SYRINGE (K091377) — FDA 510 (k) | Innolitics

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) K203359 24 fields · synced Sep 18, 2026