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510(k) K210544

Medtronic Extended infusion set by Unomedical A/S — Product Code FPA

K210544 is an FDA 510(k) premarket notification submitted by Unomedical A/S for the device "Medtronic Extended infusion set". The FDA issued a decision of Substantially Equivalent on July 16, 2021. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Unomedical A/S has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2021
Date Received
February 24, 2021
Clearance Type
Traditional
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

  • 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)
  • K041545 — CONTACT DETACH (June 30, 2004)

Other clearances for product code FPA

  • K254123 — Ecomed Disposable Administration Sets (September 11, 2026)
  • 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)

FDA data resources