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0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161552

by Becton, Dickinson and Company

Identifiers

510(k) Number
K161552 FDA 510(k)
FDA Product Code
NGT 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)

This device is a Saline, Vascular Access Flush as classified under FDA regulation 880.5200. It is a sterile, isotonic sodium chloride solution designed for flushing indwelling vascular access devices to maintain patency and prevent occlusion.

The BD PosiFlush SP Syringe is supplied as a single-use, prefilled syringe and is intended for use in general hospital settings. It is packaged externally sterile and requires no additional sterilisation. The device is classified as Class II under FDA regulations and holds a 510(k) clearance (K161552) for substantial equivalence. Sizes and variants are referenced by registration numbers, including 3034669683 and others, but the specific model number remains unchanged as provided.

Frequently asked questions

What is the primary purpose of the BD PosiFlush SP Syringe, and in which clinical settings is it typically used?

The BD PosiFlush SP Syringe is designed as a 0.9% Sodium Chloride Injection, USP, specifically for flushing indwelling vascular access devices to maintain patency and prevent occlusion. It is classified under FDA regulation 880.5200 as a *Saline, Vascular Access Flush* and is intended for use in general hospital settings, as indicated by its advisory committee classification.

Is the BD PosiFlush SP Syringe single-use or reusable, and what does that mean for its sterility?

The BD PosiFlush SP Syringe is single-use only, meaning it is intended for one-time use per patient. It is supplied externally sterile and does not require additional sterilization before use, ensuring safety and reliability for clinical applications.

Are there different sizes or models of the BD PosiFlush SP Syringe, and how are they identified?

While the device name and model remain unchanged (BD PosiFlush SP Syringe), it comes in multiple registration numbers (e.g., 3034669683, 3016707060, etc.), which likely correspond to variations in packaging or volume. These identifiers are used for regulatory tracking but do not alter the core function or composition of the product.

How should the BD PosiFlush SP Syringe be stored, and are there any special handling instructions?

The device is externally sterile and should be stored according to standard pharmaceutical practices for sterile injectables. Since it is prefilled and single-use, it should be kept in a clean, dry environment, protected from contamination, and used within the expiration date printed on the packaging. No additional sterilization is required before use.

What regulatory pathway was followed for the approval of this device, and what does that mean for its use?

The BD PosiFlush SP Syringe received FDA 510(k) clearance (K161552) under a *Special 510(k)* pathway, demonstrating substantial equivalence to a legally marketed predicate device. This means it meets FDA standards for safety and effectiveness as a Saline, Vascular Access Flush and is approved for use in general hospital settings as specified in the regulatory submission.

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: 0.9% Sodium Chloride Injection, USP 250mL - 1727170105 | BD, BD PosiFlush™ Prefilled Saline Syringe, 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (K250884 ...

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) K161552 24 fields · synced Oct 6, 2026