# K053049: Alaris Safety Male Luer

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Alaris Products
- Decided: Jan 12, 2006 after 76 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K883614 (1988). 6 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972527: Phaseal, System for Sealed Handling of Chemotherapeutic Agents, Quality System Consulting (1997) Summary page 2.
- K051437: CML 1000, Icu Medical, Inc. (2005) Summary page 2.

## Most influential descendants
- K071108: Texium Syringe (2007), 11 descendants of its own
- K083152: Equashield System (2009), 9 descendants of its own
- K091389: Equalshield Luer Lock Connector Pair (2009), 8 descendants of its own
- K101940: Equashield System Protective Plus (2010), 7 descendants of its own
- K132899: Equashield Closed System Drug Transfer Device (CSTD) (2014), 6 descendants of its own

## Recalls of this device
- May 12, 2025 · Class II · Z-1970-2025: Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connect
- May 12, 2025 · Class II · Z-1973-2025: Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connect
- Aug 30, 2007 · Not classified · Z-0218-2008: Leaks: there is a risk of leakage at the female end of the Texium closed male luer (CML) when attached to a spin luer. (NOTE: users who connect the female portion of the Texium closed male luer to fix

## Indications for use
The Safety Male Luer is indicated for use when reconstituting, dispensing/ transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The Safety Male Luer is intended for use with the SmartSite® Needle Free Valve port or standard open female luers.

Source page: https://510kreport.com/device/K053049
Methodology: https://510kreport.com/methodology