# K223076: BD Texium™ Closed Male Luer

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Mar 24, 2023 after 175 days
- Product code: ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System)
- 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: 3 generations back to K883614 (1988). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053049: Alaris Safety Male Luer, Cardinal Health, Alaris Products (2006) Summary page 4.

## Most influential descendants
- K231888: BD Texium™ Needle-Free Syringe (2023), 0 descendants of its own

## Indications for use
The BD Texium™ Closed Male Luer (CML) is a sterile, single-use closed system drug transfer device (CSTD) intended for the reconstitution, transfer and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ NFC. The BD Texium™ Closed Male Luer (CML) is indicated for use by trained healthcare professionals within healthcare facilities who prepare and/or administer non-hazardous and hazardous drugs for adults, pediatrics and neonates.

Source page: https://510kreport.com/device/K223076
Methodology: https://510kreport.com/methodology