ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS— 510(k) K022209

Clearance details

Applicant

Alaris Medical Systems, Inc.

Product code

Code FPA

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

2002-07-08

Decision date

2002-08-06

Decision

Substantially Equivalent

Clearance type

Special

Location

San Diego, CA, US

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• K251375 — PuraCath Firefly Needleless Connector IT (9005)2026-02-12
• K251257 — nSet+ Stabilization Set [6426733] +2 more2025-12-04

• K043299 — MEDLEY PCA MODULE, MODEL 81202004-12-10
• K041241 — MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 86002004-07-06
• K031741 — MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 83002004-02-09
• K032233 — MEDLEY PCA MODULE, MODEL 81202003-09-09
• K032147 — SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES2003-07-25

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-0035-2026 — BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites 10012645, Back Check Valve, Non-vented, SmartSite Y-site 2426-0500, Back Check Valve, 3 SmartSite Y-sites 2450-0500, Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite Y-sites 11522558, Ball Valve, Back Check Valve, 3 SmartSite Y-sites 2410-0500, 2 SmartSite Y-Sites 2232-0007, 0.2 Micron Filter 11613191, 0.2 Micron Filter, Ball Valve, SmartSite" Port (Burette), 2 SmartSite Y-sites 10012144, 3 SmartSite Y-Sites, Check Valve 10013034, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 4-way Stopcock 10013037, Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site 11582773, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 3-way StopcockClass I·Ongoing·CareFusion 303, Inc.·20250911
• Z-2180-2025 — BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV; REF: 2204-0007, BD Alaris Pump Infusion SetAS LVP 20D; REF: 24001-0007, BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-siteAS LVP 20D SS CV; REF: 10015012, BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-siteAS LVP BUR 20D PE-Lined SMBORE SS 0.2M; REF: 2432-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D 3SS 0.2M CV; REF: 2434-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-siteAS LVP 20D SS 0.2M CV; REF: 2202-0007, BD Alaris Pump Infusion Set, 1.2 Micron FilterAS LVP 20D 1.2M; REF: 11426965, BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sitesAS LVP 20D CV; REF: 10561554, BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D DEHP FREE 3SS 15M CV; REF: 10863358, BD Alaris Pump Infusion Set, 15 Micron FilterAS LVP 20D DEHP FREE 15M; REF: 11171447, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 20D 3SS 2CV; REF: 11532269, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sitesAS LVP 20D PE-LINED 2SS 0.2M CV; REF: 10010454, BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-siteAS LVP 20D PE-LINED TUBING SS 0.2M; REF: 2465-0007, BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, Low Sorbing Tubing (PE Lined), SmartSite Y-siteAS LVP SS BAG 20D PE-Lined SS 0.2M; REF: 10010453, ASBD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site LVP 20D PE-LINED TUBING SS 1.2M REF: 11419365, BD Alaris" Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite" Y-sites REF: 10813621, BD Alaris" Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite" Y-sites REF: 2423-0007, BD Alaris" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite" Y-sites REF: 10015896, BD Alaris" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 SmartSite" Y-sites REF: 24010-0007T, BD Alaris" Pump Infusion Set, Bonded Texium", Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite" Y-sites REF: 10010483, BD Alaris" Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing REF: 2403-0007, BD Alaris" Pump Infusion Set, Half Set, SmartSite" Y-site REF: 24301-0007T, BD Alaris" Pump Infusion Set, SmartSite" Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium" Closed Male Luer with Priming Cap, SmartSite" Y-siteClass I·Ongoing·CareFusion 303, Inc.·20250708
• Z-1944-2024 — Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.Class II·Ongoing·BD SWITZERLAND SARL·20240418
• Z-0349-2024 — BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 10010483; BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog # 10010453; BD AlarisTM Pump Infusion Set 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog # 10010454; BD AlarisTM Pump Infusion Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSiteTM Y-sites, Catalog # 10013072; BD AlarisTM Bag Access Non-Vented Back Check Valve 2 SmartSiteTM Y-Sites, Catalog # 10013361; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog # 10013890; BD AlarisTM Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSiteTM Port (Burette) SmartSiteTM Y-Site, Catalog # 10015012; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE-Lined), Catalog # 10015862; BD AlarisTM Pump Infusion Blood Set 180 Micron Filter 2 Blunt Spikes, Catalog # 10062818; BD AlarisTM Pump Infusion Buerette Set SmartSiteTM Port (Burette) 3 SmartSiteTM Y-Sites, Catalog # 10821753; BD AlarisTM Pump Infusion Set 2 Back Check Valves 3 SmartSiteTM Y-Sites, Catalog # 11171447; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog # 11426964; BD AlarisTM Pump Infusion Set 0.2 Micron Filter Back Check Valve Low Sorbing Tubing (PE Lined) 2 SmartSiteTM Y-sites, Catalog # 11532269; BD AlarisTM Pump Infusion Buerette Set 0.2Micron Filter Ball Valve SmartSiteTM Port (Burette) 2 SmartSiteTM Y-Sites, Catalog # 11613191; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog # 10015861A; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM ClosedMale LuerWith PrimingCAP, Catalog # 22000-B007T; BD AlarisTM Pump Infusion Set 1.2 Micron Filter, Catalog # 2202-0007; BD AlarisTM Pump Infusion Set, Catalog # 2204-0007; BD AlarisTM Pump Infusion Set Yellow-Striped Microbore Tubing, Catalog # 2206-0007; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog # 2260-0500; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22600-0007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22601-B007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22602-B007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22603-B007T; BD AlarisTM Pump Infusion Set Back Check Valve SmartSiteTM Y-site, Catalog # 24001-0007; BD AlarisTM Pump Infusion Set Half Set SmartSiteTM Y-site, Catalog # 2403-0007; BD AlarisTMPumpInfusionSetSmartsiteTM BagAcessNon-Vented0.2MicronFilterBondedTexiumTMClosedLowSorbingTubing(PELined)MaleLuerwithprimingcapSmartSiteTMY-site, Catalog # 24301-0007T; BD AlarisTM Pump Infusion Buerette Set Smallbore Tubing SmartsiteTM Port (Burette) 3 SmartSiteTM Y-Site, Catalog # 2441-0007; BD AlarisTM Pump Infusion Set Back Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSiteTM Y-sites, Catalog # 2450-0500; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog # 24600-0007; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing TexiumTM Back Check Valve 2 SmartSiteTM Y-sites, Catalog # 24601-B007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-Site, Catalog # 2465-0007; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined), Catalog # 2466-0007.Class II·Ongoing·Becton Dickinson & Company·20231011
• Z-0350-2024 — BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.Class II·Ongoing·Becton Dickinson & Company·20231011
• Z-0351-2024 — BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog # 20062E; BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog # 70000N-07; BD MaxGuardTM tri-fuse extension set, Catalog # ME1224; BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog # 20350ET; BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog # 70001B-07T.Class II·Ongoing·Becton Dickinson & Company·20231011

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022209.