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510(k) K131123

CLICKFINE AUTOPROTECT PEN NEEDLE by Ypsomed AG — Product Code FMI

K131123 is an FDA 510(k) premarket notification submitted by Ypsomed AG for the device "CLICKFINE AUTOPROTECT PEN NEEDLE". The FDA issued a decision of Substantially Equivalent on July 5, 2013. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Ypsomed AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2013
Date Received
April 22, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
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)
  • K131125 — CLICKFINE PEN NEEDLE (July 5, 2013)
  • K130468 — ORBIT INFUSION SET (March 19, 2013)
  • K110312 — CLICKFINE AUTOPROTECT PEN NEEDLE (January 26, 2012)
  • K102108 — CLICKFINE PEN NEEDLE (November 23, 2010)

Other clearances for product code FMI

  • K260739 — Profoject™ Pen Needles (Model A; Model B) (July 15, 2026)
  • K260855 — Profoject™ Safety Pen Needles (June 10, 2026)
  • K254273 — Verisafe Safety Sterile Needles (SSN) (April 16, 2026)
  • K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen (March 25, 2026)
  • K253047 — PRESSONE™ (March 24, 2026)
  • K253622 — Safety Pen Needle (March 18, 2026)
  • K252886 — Pen Needle (January 6, 2026)
  • K250700 — Pen Injector Needle 32.5 (November 21, 2025)
  • K252631 — Profoject™ Disposable Needle (October 16, 2025)
  • K250724 — Intraosseous Infusion Needles (July 30, 2025)

FDA data resources