0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE— 510(k) K121050

Clearance details

Applicant

Becton, Dickinson & CO

Product code

Code NGT

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2012-04-06

Decision date

2013-02-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Franklin Lakes, NJ, US

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• K141474 — BECTON DICKINSON INTELLIPORT SYSTEM2014-12-18
• K140446 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY2014-05-20
• K140448 — BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY2014-05-20

Death

12

Malfunction

2,008

Other

4

Total

2,024

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2673-2014 — BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps.Class II·Terminated·Becton Dickinson & Company·20140722

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121050.