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510(k) K022209

ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS by Alaris Medical Systems, Inc. — Product Code FPA

K022209 is an FDA 510(k) premarket notification submitted by Alaris Medical Systems, Inc. for the device "ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS". The FDA issued a decision of Substantially Equivalent on August 6, 2002. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Alaris Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2002
Date Received
July 8, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Alaris Medical Systems, Inc.

  • K043299 — MEDLEY PCA MODULE, MODEL 8120 (December 10, 2004)
  • K041241 — MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 (July 6, 2004)
  • K031741 — MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 (February 9, 2004)
  • K032233 — MEDLEY PCA MODULE, MODEL 8120 (September 9, 2003)
  • K032147 — SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 7 (July 25, 2003)
  • K030459 — MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) (April 4, 2003)
  • K023264 — MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 (December 19, 2002)
  • K022677 — MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE (September 11, 2002)
  • K013087 — SINGLE DOSE DISPENSING PIN, MODEL 2201 (November 13, 2001)
  • K012383 — GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM I (October 2, 2001)

Other clearances for product code FPA

  • K261530 — iiSure Infusion Set (June 3, 2026)
  • K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, (May 4, 2026)
  • K251375 — PuraCath Firefly Needleless Connector IT (9005) (February 12, 2026)
  • K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Fre (December 4, 2025)
  • K250325 — BD Alaris Pump Infusion Set (October 30, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)
  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)

FDA data resources