Ypsomed AG - FDA 510(k) Cleared Devices

Cleared Aug 28, 2025

SmartPilot YpsoMate NS-A2.25

K243901 · QOG

General Hospital · 252d

Cleared Oct 11, 2017

Clickfine Pen Needle, Penfine Classic Pen Needle

K171984 · FMI

General Hospital · 103d

Cleared Jul 26, 2017

Orbit Inserter

K163400 · KZH

General Hospital · 233d

Cleared Apr 12, 2016

Orbit Infusion Set

K150921 · FPA

General Hospital · 372d

Cleared Nov 18, 2015

Clickfine AutoProtect Pen Needle

K152514 · FMI

General Hospital · 77d

Cleared Jun 09, 2015

Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)

K150662 · FMI

General Hospital · 88d

Cleared Jul 05, 2013

CLICKFINE AUTOPROTECT PEN NEEDLE

K131123 · FMI

General Hospital · 74d

Cleared Jul 05, 2013

CLICKFINE PEN NEEDLE

K131125 · FMI

General Hospital · 74d

Cleared Mar 19, 2013

ORBIT INFUSION SET

K130468 · FPA

General Hospital · 22d

Cleared Jan 26, 2012

CLICKFINE AUTOPROTECT PEN NEEDLE

K110312 · FMI

General Hospital · 358d

Cleared Nov 23, 2010

CLICKFINE PEN NEEDLE

K102108 · FMI

General Hospital · 119d

Cleared Apr 30, 2010

CLICKFINE PEN NEEDLE

K100436 · FMI

General Hospital · 73d