← Back to catalogue

0.9% Sodium Chloride Injection, USP, BD PosiFlush SP Syringe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250884

by Becton, Dickinson and Company

Identifiers

510(k) Number
K250884 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)

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush SP Syringe is a sterile, nonpyrogenic parenteral solution classified as a Saline, Vascular Access Flush. It is formulated as a 0.9% sodium chloride solution in water for injection, designed for intravenous administration and maintenance of vascular access devices.

This device is supplied as a single-use syringe and is intended for flushing indwelling vascular access devices in general hospital settings. It adheres to FDA regulatory standards under 510K clearance (K250884) and is categorized under Device Class II (880.5200). The product is non-sterile upon packaging but is sterilized prior to use, ensuring compatibility with standard hospital protocols.

Frequently asked questions

What is the primary use of the BD PosiFlush SP Syringe in clinical settings?

The BD PosiFlush SP Syringe is designed specifically for flushing indwelling vascular access devices in general hospital settings. It contains a 0.9% sodium chloride solution, which helps maintain the patency of intravenous lines by preventing clotting and ensuring proper function of the vascular access.

Is the BD PosiFlush SP Syringe intended for single-use or can it be reused?

The BD PosiFlush SP Syringe is explicitly labeled as a single-use device. While it is packaged in a non-sterile state, it undergoes sterilization prior to use, which aligns with standard hospital protocols for single-use parenteral solutions. Reuse is not recommended or supported by the manufacturer.

How is the sterility of the BD PosiFlush SP Syringe ensured before clinical use?

The device is sterilized prior to use, though it is packaged in a non-sterile state. This means hospitals must follow standard sterilization protocols (e.g., terminal sterilization) before administering the solution to patients. The manufacturer ensures compatibility with these protocols to maintain safety and efficacy.

What regulatory pathway was followed for FDA clearance of this device?

The BD PosiFlush SP Syringe received FDA clearance under a 510(k) submission (K250884), classified as Substantially Equivalent to a predicate device. The clearance was granted by the Hemodynamics (HO) Advisory Committee under the Traditional 510(k) Review pathway, with a decision date of December 2, 2025. It falls under Device Class II (880.5200) and is categorized for use in general hospital settings.

Are there multiple sizes or models available for the BD PosiFlush SP Syringe?

The provided data does not specify exact syringe sizes or models, but the device is listed under Product Code NGT and includes multiple FEI numbers, which typically correspond to different lot or batch identifiers rather than distinct sizes. For precise sizing (e.g., 3mL, 5mL, 10mL), refer to the manufacturer’s official product catalog or packaging.

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, 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (K250884 ..., 0.9% Sodium Chloride Injection, USP - DailyMed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (1)

  • FDA 510(k) K250884 24 fields · synced Sep 18, 2026