Ypsomed AG
Ypsomed AG appears in FDA public data with 0 recalls, 12 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Aug 28, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 4
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K243901 | SmartPilot YpsoMate NS-A2.25 | Aug 28, 2025 |
| K171984 | Clickfine Pen Needle, Penfine Classic Pen Needle | Oct 11, 2017 |
| K163400 | Orbit Inserter | Jul 26, 2017 |
| K150921 | Orbit Infusion Set | Apr 12, 2016 |
| K152514 | Clickfine AutoProtect Pen Needle | Nov 18, 2015 |
| K150662 | Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) | Jun 9, 2015 |
| K131125 | CLICKFINE PEN NEEDLE | Jul 5, 2013 |
| K131123 | CLICKFINE AUTOPROTECT PEN NEEDLE | Jul 5, 2013 |
| K130468 | ORBIT INFUSION SET | Mar 19, 2013 |
| K110312 | CLICKFINE AUTOPROTECT PEN NEEDLE | Jan 26, 2012 |
| K102108 | CLICKFINE PEN NEEDLE | Nov 23, 2010 |
| K100436 | CLICKFINE PEN NEEDLE | Apr 30, 2010 |