Atlas FDA

ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS

FDA 510(k) clearance K022209 · decided 2002-08-06

Clearance details

K-number
K022209
Device name
ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
Applicant
Alaris Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2002-07-08
Decision date
2002-08-06
Days to decision
29 days
Clearance type
Special
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 1 recall (Z-0035-2026)CareFusion 303, Inc.2025-10-08
BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, recall (Z-2180-2025)CareFusion 303, Inc.2025-08-06
Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Site recall (Z-1944-2024)BD SWITZERLAND SARL2024-05-31
BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vente recall (Z-0349-2024)Becton Dickinson & Company2023-11-17
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PO recall (Z-0350-2024)Becton Dickinson & Company2023-11-17
BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Sta recall (Z-0351-2024)Becton Dickinson & Company2023-11-17
Alaris SE Pump (formerly Signature Edition Infusion Pump); Model Numbers: 7000, 7100, 7101 recall (Z-1484-06)Cardinal Health 303 Inc DBA Alaris Products2006-09-19