Ypsomed AG

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243901SmartPilot YpsoMate NS-A2.25August 28, 2025
K171984Clickfine Pen Needle, Penfine Classic Pen NeedleOctober 11, 2017
K163400Orbit InserterJuly 26, 2017
K150921Orbit Infusion SetApril 12, 2016
K152514Clickfine AutoProtect Pen NeedleNovember 18, 2015
K150662Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)June 9, 2015
K131123CLICKFINE AUTOPROTECT PEN NEEDLEJuly 5, 2013
K131125CLICKFINE PEN NEEDLEJuly 5, 2013
K130468ORBIT INFUSION SETMarch 19, 2013
K110312CLICKFINE AUTOPROTECT PEN NEEDLEJanuary 26, 2012
K102108CLICKFINE PEN NEEDLENovember 23, 2010
K100436CLICKFINE PEN NEEDLEApril 30, 2010