Cleared Traditional

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

K250884 · Becton, Dickinson and Company · General Hospital

Dec 2025

Decision

253d

Days

Class 2

Risk

About This 510(k) Submission

K250884 is an FDA 510(k) clearance for the 0.9 % Sodium Chloride Injection, USP, BD PosiFlush? SP Syringe, a Saline, Vascular Access Flush (Class II — Special Controls, product code NGT), submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on December 2, 2025, 253 days after receiving the submission on March 24, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K250884 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 2025
Decision Date	December 02, 2025
Days to Decision	253 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	NGT — Saline, Vascular Access Flush
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200
Definition	Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use.