0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe— 510(k) K161552
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K161552 for 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe, Substantially Equivalent on 2017-02-02. Applicant: Becton, Dickinson and Company. Device class: 2.
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Franklin Lakes, NJ, US
Recent devices under product code NGT
view all- K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe
- K233623 — Praxiject SP 0.9% NaCl
- K231724 — Flush Syringe (Prefilled 0.9% normal saline solution)
- K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
- K223584 — Pre-Filled Normal Saline Flush Syringe
More clearances from Becton, Dickinson and Company
view all- K260128 — BD Preset and BD A-Line Arterial Blood Collection Syringes
- K252378 — BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube
- K252506 — BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder
- K260184 — Onclarity Self-Collection Kit
- K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
Adverse events under product code NGT
product code NGT- Death
- 12
- Malfunction
- 2,008
- Other
- 4
- Total
- 2,024
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K161552
K-number listed on FDA's recall record- Z-0736-2024 — PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
- Z-0499-2020 — BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
- Z-0500-2020 — BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161552.
Data sourced from openFDA. This site is unofficial and independent of the FDA.