FDA 510(k)

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

K-Number: K250884 · 2025-12-02

Decision Date2025-12-02

Product CodeNGT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2025-12-02 under 510(k) 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. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K250884.

When did 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe receive FDA 510(k) clearance?

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

Who is the listed applicant for 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05957406SMART TRENDS StudyCOMPLETED NCT06492746Personal BP - CAI StudyRECRUITING NCT07148323HemoSphere Alta StudyRECRUITING NCT07216573The Continuity StudyRECRUITING NCT07317648ClearSight NextGen1 StudyCOMPLETED

Other records listing Becton, Dickinson and Company as applicant

PMA P160037KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS K260128BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube K260184Onclarity™ Self-Collection Kit K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

View all 100 devices →

Related Devices (Code: NGT)

K233623Praxiject™ SP 0.9% NaClMedxl, Inc.K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt. , Ltd.K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd.K230756TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd.K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd.K2311610.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush SyringeBecton, Dickinson and Company

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.