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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saline, Vascular Access Flush
510(k) Number K250884
Device Name 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
Applicant
Becton, Dickinson and Company
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact Michael Pacelli
Correspondent
Becton, Dickinson and Company
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact Anamika Tiwari
Regulation Number880.5200
Classification Product Code
NGT  
Date Received03/24/2025
Decision Date 12/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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