# K231888: BD Texium™ Needle-Free Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Sep 25, 2023 after 90 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K883614 (1988). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071108: Texium Syringe, Cardinal Health, Alaris Products (2007) Summary page 4.
- K223076: BD Texium™ Closed Male Luer, Care Fusion (2023) Summary page 5.

## Indications for use
The BD Texium™ Needle-Free Syringe is a sterile, single-use closed system drug transfer device (CSTD) incorporating a bonded Texium™ Closed Male Luer and Syringe, intended for preparation and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ Needle-free Connector (NFC). When paired with devices containing a SmartSite™ NFC the BD Texium™ Needle-Free Syringe mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the BD Texium™ Needle-Free Syringe/SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks, and spills. (e.g., airtight, leak-free and drip-free).

Source page: https://510kreport.com/device/K231888
Methodology: https://510kreport.com/methodology