# Ypsomed AG

- Location (FDA's records): Burgdorf, CH
- FDA decisions: 12 (2010–2025): 12 510(k) clearances
- Product codes: FMI (8), FPA (2), QOG (1), KZH (1)
- 510(k) review time since 2016: median 252 days, against 195 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 14 (5 its own); citations of its devices by later devices: 10 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Becton, Dickinson & CO: 3 (https://510kreport.com/company/becton-dickinson)
- Disetronic Medical Systems: 2 (https://510kreport.com/company/disetronic-medical-systems)
- P/L Biomedical: 2 (https://510kreport.com/company/p-l-biomedical)
- Icu Medical, Inc.: 1 (https://510kreport.com/company/icu-medical)
- Biocorp Production: 1 (https://510kreport.com/company/biocorp-production)

## Firms that cite its devices most
- P/L Biomedical: 2 (https://510kreport.com/company/p-l-biomedical)
- Berpu Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/berpu-medical-technology)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)
- Sandstone Medical (Suzhou), Inc.: 1 (https://510kreport.com/company/sandstone-medical-suzhou)

## Its most-cited devices
- K130468: Orbit Infusion Set (2013), cited by 2
- K152514: Clickfine AutoProtect Pen Needle (2015), cited by 2
- K102108: Clickfine Pen Needle (2010), cited by 2
- K100436: Clickfine Pen Needle (2010), cited by 1
- K131123: Clickfine Autoprotect Pen Needle (2013), cited by 1
- K131125: Clickfine Pen Needle (2013), cited by 1

## Recent decisions
- 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)
- K131123: Clickfine Autoprotect Pen Needle (Jul 5, 2013)
- K131125: Clickfine Pen Needle (Jul 5, 2013)

Source page: https://510kreport.com/company/ypsomed