0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe— 510(k) K153481

Clearance details

Applicant

Becton, Dickinson and Company

Product code

Code NGT

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2015-12-03

Decision date

2016-04-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Franklin Lakes, NJ, US

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• K233623 — Praxiject SP 0.9% NaCl2024-02-27
• K231724 — Flush Syringe (Prefilled 0.9% normal saline solution)2023-11-09
• K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)2023-09-27
• K223584 — Pre-Filled Normal Saline Flush Syringe2023-08-12

• K260128 — BD Preset and BD A-Line Arterial Blood Collection Syringes2026-04-15
• K252378 — BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube2026-04-10
• K252506 — BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder2026-04-10
• K260184 — Onclarity Self-Collection Kit2026-04-02
• K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes2026-03-13

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-2065-2020 — BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535Class II·Terminated·Becton Dickinson & Company·20200416

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153481.