Home / 510(k) Clearances / K032854

510(k) K032854

UNOMEDICAL MONICA INFUSION SET by Unomedical A/S — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2003
Date Received
September 12, 2003
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 Unomedical A/S

  • K210544 — Medtronic Extended infusion set (July 16, 2021)
  • K192647 — neria guard Infusion Set (December 13, 2019)
  • K173879 — MiniMed Mio Advance infusion set (March 5, 2018)
  • K162812 — Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutane (November 1, 2017)
  • K160648 — MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® (August 10, 2016)
  • K132142 — NERIA SOFT 90 INFUSION SET (October 8, 2013)
  • K120337 — I-PORT ADVANCE INJECTION PORT (February 16, 2012)
  • K070430 — PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS (April 4, 2007)
  • K061374 — INTUITION INFUSION SETS (July 31, 2006)
  • K051264 — COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS (September 1, 2005)

Other clearances for product code FPA

  • 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)
  • K242692 — SteadiSet Infusion Set (May 9, 2025)
  • K242763 — JetCan® Pro Safety Huber Needle (May 2, 2025)