Ypsomed AG
BURGDORF Bern, CH
YPSOMED AG appears in FDA device records in BURGDORF Bern, CH. FDA records list 12 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Ypsomed AG between 2010 and 2025. The busiest year on record is 2013, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 2 |
| 2012 | 1 |
| 2013 | 3 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243901 | SmartPilot YpsoMate NS-A2.25 | QOG | Substantially Equivalent | |
| K171984 | Clickfine Pen Needle, Penfine Classic Pen Needle | FMI | Substantially Equivalent | |
| K163400 | Orbit Inserter | KZH | Substantially Equivalent | |
| K150921 | Orbit Infusion Set | FPA | Substantially Equivalent | |
| K152514 | Clickfine AutoProtect Pen Needle | FMI | Substantially Equivalent | |
| K150662 | Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) | FMI | Substantially Equivalent | |
| K131125 | CLICKFINE PEN NEEDLE | FMI | Substantially Equivalent | |
| K131123 | CLICKFINE AUTOPROTECT PEN NEEDLE | FMI | Substantially Equivalent | |
| K130468 | ORBIT INFUSION SET | FPA | Substantially Equivalent | |
| K110312 | CLICKFINE AUTOPROTECT PEN NEEDLE | FMI | Substantially Equivalent | |
| K102108 | CLICKFINE PEN NEEDLE | FMI | Substantially Equivalent | |
| K100436 | CLICKFINE PEN NEEDLE | FMI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002806818 | 3002806818 | YPSOMED AG | BRUNNMATTSTRASSE 6, BURGDORF Bern CH-3401 CH | 2026 | |
| 3005170966 | 3005170966 | YPSOMED AG | WEISSENSTEINSTRASSE 26, SOLOTHURN, SOLOTHURN CH-4503 CH | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain