Becton, Dickinson and Company · Class II · Cleared Dec 2, 2025
| K-number | K250884 |
| Device name | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe |
| Applicant | Becton, Dickinson and Company |
| Product code | NGT |
| Device class | Class II |
| Decision date | Dec 2, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 880.5200 |
The BD PosiFlush SP Syringe is a single-use, sterile, prefilled syringe containing 0.9% sodium chloride injection USP. It has a Luer connector compatible with ISO 80369-7:2021 small-bore connectors and is intended solely for flushing indwelling vascular access devices.
The subject device is a 10 mL three-piece syringe with polypropylene barrel and tip cap, polypropylene plunger rod, styrene-butadiene rubber stopper, and silicone lubricants. It differs from the predicate (which offered 3, 5, and 10 mL sizes) by offering only the 10 mL configuration and uses different resin materials for the barrel and tip cap, though all components are identical or functionally equivalent.
ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-23 (irritation), ISO 10993-11 (acute systemic toxicity and pyrogenicity), ISO 10993-4 (hemocompatibility), ASTM F756-17 (hemolysis), and USP monographs for 0.9% sodium chloride injection and various container/content tests.
The subject device performs identically to predicate K161552 in all performance, packaging, and biocompatibility testing, with all acceptance criteria met. Despite material and configuration differences, comprehensive nonclinical testing demonstrates no new or different questions of safety and effectiveness, establishing substantial equivalence for vascular access flushing applications.
View the full FDA submission: accessdata.fda.gov