# K233021: BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Mar 6, 2024 after 166 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K901063 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970485: Smartsite Access Pin, Ivac Medical Systems (1997) Summary page 5.

## Indications for use
Vial access devices with SmartSite™ are standalone, single-vial use, disposable devices which provide access to a medication vial without the use of a needle during medication preparation. BD standalone vial access devices are not intended to be used on a patient.

Source page: https://510kreport.com/device/K233021
Methodology: https://510kreport.com/methodology