Medical Device Manufacturer · CH , Burgdorf

Ypsomed AG

12 submissions · 12 cleared · Since 2010
12
Total
12
Cleared
0
Denied

Ypsomed AG — FDA 510(k) Submissions

Ypsomed AG has submitted 12 FDA 510(k) premarket notifications since 2010, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Needle, Hypodermic, Single Lumen, Set, Administration, Intravascular, Introducer, Syringe Needle, Injection Data Capture Device . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
SmartPilot YpsoMate NS-A2.25
K243901 · QOG Injection Data Capture... · General Hospital
Aug 2025 252d
Clickfine Pen Needle, Penfine Classic Pen Needle
K171984 · FMI Needle, Hypodermic,... · General Hospital
Oct 2017 103d
Orbit Inserter
K163400 · KZH Introducer, Syringe Needle · General Hospital
Jul 2017 233d
Orbit Infusion Set
K150921 · FPA Set, Administration,... · General Hospital
Apr 2016 372d
Clickfine AutoProtect Pen Needle
K152514 · FMI Needle, Hypodermic,... · General Hospital
Nov 2015 77d
Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)
K150662 · FMI Needle, Hypodermic,... · General Hospital
Jun 2015 88d
CLICKFINE AUTOPROTECT PEN NEEDLE
K131123 · FMI Needle, Hypodermic,... · General Hospital
Jul 2013 74d
CLICKFINE PEN NEEDLE
K131125 · FMI Needle, Hypodermic,... · General Hospital
Jul 2013 74d
ORBIT INFUSION SET
K130468 · FPA Set, Administration,... · General Hospital
Mar 2013 22d
CLICKFINE AUTOPROTECT PEN NEEDLE
K110312 · FMI Needle, Hypodermic,... · General Hospital
Jan 2012 358d
CLICKFINE PEN NEEDLE
K102108 · FMI Needle, Hypodermic,... · General Hospital
Nov 2010 119d
CLICKFINE PEN NEEDLE
K100436 · FMI Needle, Hypodermic,... · General Hospital
Apr 2010 73d
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