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510(k) K130468

ORBIT INFUSION SET by Ypsomed AG — Product Code FPA

K130468 is an FDA 510(k) premarket notification submitted by Ypsomed AG for the device "ORBIT INFUSION SET". The FDA issued a decision of Substantially Equivalent on March 19, 2013. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Ypsomed AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2013
Date Received
February 25, 2013
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 Ypsomed AG

  • K243901 — SmartPilot YpsoMate NS-A2.25 (August 28, 2025)
  • K171984 — Clickfine Pen Needle, Penfine Classic Pen Needle (October 11, 2017)
  • K163400 — Orbit Inserter (July 26, 2017)
  • K150921 — Orbit Infusion Set (April 12, 2016)
  • K152514 — Clickfine AutoProtect Pen Needle (November 18, 2015)
  • K150662 — Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) (June 9, 2015)
  • K131123 — CLICKFINE AUTOPROTECT PEN NEEDLE (July 5, 2013)
  • K131125 — CLICKFINE PEN NEEDLE (July 5, 2013)
  • K110312 — CLICKFINE AUTOPROTECT PEN NEEDLE (January 26, 2012)
  • K102108 — CLICKFINE PEN NEEDLE (November 23, 2010)

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