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0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231161

by Becton, Dickinson and Company

Identifiers

510(k) Number
K231161 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, classified as a Class II medical device under FDA regulations. It is a sterile, single-use injection of 0.9% sodium chloride solution designed for flushing vascular access ports, catheters, and intravenous lines to maintain patency and prevent occlusion.

The syringe is supplied as a sterile, prefilled solution intended for single-use in clinical settings such as general hospitals. It adheres to FDA clearance (510(k) K231161) and is manufactured under regulatory standards (880.5200). Available in various sizes, it is packaged externally sterile and must be stored according to manufacturer guidelines to preserve sterility.

Frequently asked questions

What clinical scenarios is this saline flush syringe designed to maintain or restore?

This BD PosiFlush™ SF Saline Flush Syringe is specifically designed for flushing vascular access ports, catheters, and intravenous lines to maintain patency and prevent occlusion. It is intended for use in clinical settings like general hospitals where vascular access devices may become clogged or blocked over time.

Is this syringe reusable, or is it meant for single-use only?

The BD PosiFlush™ SF Saline Flush Syringe is explicitly labeled for single-use only. It is supplied as a sterile, prefilled solution, and reuse is not recommended or supported by the manufacturer to ensure patient safety and sterility.

What sizes are available for this saline flush syringe, and how do I know which one to choose?

While the exact sizes are not detailed in the provided data, the device is listed under multiple OpenFDA registration numbers, indicating multiple prefilled syringe sizes are available. The manufacturer’s labeling or product documentation should specify the volume (e.g., 3mL, 5mL, 10mL) for clinical selection. Always verify the size against the intended application (e.g., smaller catheters may require a lower-volume syringe).

How should I store this product to ensure it remains sterile and effective?

The BD PosiFlush™ SF Saline Flush Syringe is packaged externally sterile, so storage must follow manufacturer guidelines to preserve sterility. Typically, this means keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination by ensuring the packaging remains intact until use.

What regulatory pathway was followed for FDA clearance, and how does that affect its use?

This device received FDA 510(k) clearance (K231161) under the Traditional 510(k) pathway, determined to be substantially equivalent to a predicate device. The clearance confirms it meets FDA safety and performance standards for a Class II medical device (Saline, Vascular Access Flush). Clinically, this means it adheres to rigorous manufacturing standards (e.g., 880.5200) and is approved for use in general hospital settings as specified.

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, K231161 FDA 510 (k) - 0.9% Sodium Chloride Injection

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) K231161 24 fields · synced Oct 6, 2026