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FDA 510(k)

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

K-Number: K250884 · 2025-12-02

ApplicantBecton, Dickinson and Company
Decision Date2025-12-02
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2025-12-02 under approval number K250884. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe?

0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is a medical device that received FDA 510(k) clearance on 2025-12-02. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K250884.

When was 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe approved by the FDA?

0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe received FDA 510(k) clearance on 2025-12-02, under approval number K250884.

What company makes 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe?

0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is manufactured by Becton, Dickinson and Company.

What is the FDA product code for 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe?

The FDA product code for 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is NGT.

Related Clinical Trials

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Related Devices (Code: NGT)

K1534810.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeBecton, Dickinson and Company K171109Praxiject 0.9% NaClMedxl, Inc. K1615520.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company K1733480.9% Sodium Chloride Injection, USPMedline Industries, Inc. K1913780.9% Sodium Chloride Injection, USP, Pre-filled COP SyringeMedline Industries, Inc. K183473AMSafe(R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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