BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device

No FDA recalls found in the data synced 25 Oct 2026.

510(k) Number

K233021 ↗

FDA Product Code

LHI

Models / Variants

BD SmartSite™ 13mm Vial Access Device

BD SmartSite™ 20mm Vial Access Device

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• What are the key differences between the 13mm and 20mm variants of the BD SmartSite Vial Access Device, and how do they relate to vial compatibility?

  The BD SmartSite Vial Access Device comes in two sizes—13mm and 20mm—to match standard vial neck diameters. The 13mm variant is designed for smaller vials (typically 13mm necks), while the 20mm variant accommodates larger vials (20mm necks). Both provide a needle-free, closed-system interface for safe fluid withdrawal and injection, ensuring syringe compatibility while minimizing contamination risk. The sizing ensures a secure seal with the vial, preventing leaks or spills during use.

• How is the BD SmartSite Vial Access Device intended to improve safety compared to traditional vial access methods?

  The BD SmartSite Vial Access Device eliminates the need for needles by using a needle-free connector with a valve mechanism, which allows multiple connections while maintaining a closed system. This design reduces the risk of contamination, needle-stick injuries, and medication exposure during drug transfer. The valve ensures sterility is preserved between uses, making it ideal for closed-system drug transfer in hospital settings where minimizing contamination is critical.

• Is the BD SmartSite Vial Access Device reusable, or is it meant for single-use only? What does this mean for inventory management?

  The BD SmartSite Vial Access Device is supplied as a single-use item, meaning each unit is intended for one patient or one procedure before disposal. This design choice aligns with aseptic medical device protocols to prevent cross-contamination between patients. For inventory management, this means stocking must account for per-use consumption, and unused devices should not be reused or reprocessed, as they are not designed for sterilization beyond their original packaging.

• What storage conditions should be followed for the BD SmartSite Vial Access Device to maintain its sterility and functionality?

  The device should be stored following standard aseptic medical device protocols, which typically include keeping it in its original, unopened packaging to preserve sterility. It should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. Since it is single-use, it should not be exposed to conditions that could compromise its integrity before first use, such as prolonged exposure to moisture or physical damage.

• What regulatory pathway was followed for the FDA clearance of the BD SmartSite Vial Access Device, and what does this mean for its intended use?

  The BD SmartSite Vial Access Device received FDA clearance under the 510(k) pathway (K233021), specifically classified as substantially equivalent (SESE) to a predicate device. This clearance was granted by the Hospital/Outpatient (HO) Advisory Committee and confirms its compliance for general hospital use, particularly for closed-system drug transfer in sterile environments. The clearance does not specify clinical indications but confirms its safety and effectiveness for the described needle-free vial access purpose in hospital settings.