# K223088: BD SmartSite™ Needle-Free Connector

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Apr 7, 2023 after 189 days
- Product code: FPA (Set, Administration, Intravascular)
- 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 K960280 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061285: Smartsite Needle Free Valve Administration Sets, Cardinal Health, Alaris Products (2006) Summary page 4.

## Indications for use
The BD SmartSite™ Needle-Free Connector (NFC) is a sterile, single patient use connector for needle free access to the IV line and/or IV catheter during IV therapy. The BD SmartSite™ NFC can be used for direct injection, intermittent infusion and/or the continuous infusion of fluids, drugs, IV nutrition, lipids, and/or blood/blood products or the aspiration of blood. The BD SmartSite™ NFC may be used with power injector procedures to a maximum pressure of 325 psi up to a flow rate of 10 mL per second.

Source page: https://510kreport.com/device/K223088
Methodology: https://510kreport.com/methodology