Ypsomed AG: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Ypsomed AG” (first 2010, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 96 days. Since 2017 the median was 233 days, against 190 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 358 |
| 2013 | 3 | 74 |
| 2014 | 0 | — |
| 2015 | 2 | 82 |
| 2016 | 1 | 372 |
| 2017 | 2 | 168 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 252 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ypsomed AG took a median 233 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 190 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 8 | 8 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| KZH | Introducer, Syringe Needle | 1 | 1 |
| QOG | Injection Data Capture Device | 1 | 1 |
Review panels
- General Hospital (12)
Most recent Ypsomed AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243901 | SmartPilot YpsoMate NS-A2.25 | QOG | 2025-08-28 | 252 |
| K171984 | Clickfine Pen Needle, Penfine Classic Pen Needle | FMI | 2017-10-11 | 103 |
| K163400 | Orbit Inserter | KZH | 2017-07-26 | 233 |
| K150921 | Orbit Infusion Set | FPA | 2016-04-12 | 372 |
| K152514 | Clickfine AutoProtect Pen Needle | FMI | 2015-11-18 | 77 |
| K150662 | Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) | FMI | 2015-06-09 | 88 |
| K131125 | CLICKFINE PEN NEEDLE | FMI | 2013-07-05 | 74 |
| K131123 | CLICKFINE AUTOPROTECT PEN NEEDLE | FMI | 2013-07-05 | 74 |
| K130468 | ORBIT INFUSION SET | FPA | 2013-03-19 | 22 |
| K110312 | CLICKFINE AUTOPROTECT PEN NEEDLE | FMI | 2012-01-26 | 358 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ypsomed AG.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ypsomed AG?
FDA lists 12 510(k) clearances under the applicant name “Ypsomed AG” (first 2010, latest 2025), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ypsomed AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ypsomed AG is 96 days. Since 2017: 233 days, versus 190 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ypsomed AG?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 8); FPA (Set, Administration, Intravascular, 2); KZH (Introducer, Syringe Needle, 1).
Next steps
- See all 12 Ypsomed AG clearances with predicates and recalls
- Run predicate analysis for product code FMI, Ypsomed AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.