ALARIS SAFETY MALE LUER— 510(k) K053049

Clearance details

Applicant

Cardinal Health, Alaris Products

Product code

Code FPA

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

2005-10-28

Decision date

2006-01-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Diego, CA, US

• K254123 — Ecomed Disposable Administration Sets2026-09-11
• K261530 — iiSure Infusion Set2026-06-03
• K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)2026-05-04
• K251375 — PuraCath Firefly Needleless Connector IT (9005)2026-02-12
• K251257 — nSet+ Stabilization Set [6426733] +2 more2025-12-04

• K071400 — SMARTSITE STOPCOCK2007-12-14
• K071108 — TEXIUM SYRINGE2007-05-24
• K061285 — SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS2006-07-26
• K052790 — SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD2005-12-23
• K051641 — ALARIS SYSTEM PC UNIT, MODEL 80012005-10-20

Death

95

Injury

14,421

Malfunction

125,815

Other

30

Total

140,361

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1970-2025 — Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium Closed Male Luer With Priming Cap, REF: 22000-B007T; Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, REF: 22600-0007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22603-B007T; Bonded Texium Closed Male Luer with priming cap Back Check Valve 2 SmartSite Y-Sites, REF: 24010-0007T; SmartSite Bag Access Non-Vented 0.2 MicronFilter Bonded Texium Closed Low Sorbing Tubing (PE Lined) Male Luer with priming cap SmartSite Y-site, REF: 24301-0007T; SmartSite Bag Access Non-Vented Low Sorbing Texium Back Check Valve 2 SmartSite Y-Sites, REF: 24601-B007T. BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TEXIUMTM AND HANGER LOW SORBING, REF: 70001B-07T; BD 20-IN EXTENSION SET W/0.2 MICRON FILTER ONE SmartSite VALVE AND Texium, REF: 20350ET; BD Secondary Set 20 Drop Vented Non Vented With Texium & Hanger, REF: 40000-07T; BD 20 DROP SECONDARY SET SmartSite VALVE BAG ACCESS W/TEXIUM CLOSED MALE LUER HANGER, REF: 10013364T; BD 32-IN GRAV SET MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, REF: 4030B-07T; BD Texium Smartsite MICROBORE EXTENSION SET 60 IN, REF: 22005E-07TClass II·Ongoing·BD SWITZERLAND SARL·20250512
• Z-1973-2025 — BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500Class II·Ongoing·BD SWITZERLAND SARL·20250512

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053049.