Cascination AG: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Cascination AG” (first 2015, latest 2025), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 220 days. Since 2017 the median was 258 days, against 128 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 |
|---|---|---|
| 2015 | 1 | 189 |
| 2016 | 1 | 142 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 266 |
| 2022 | 1 | 142 |
| 2023 | 0 | — |
| 2024 | 1 | 250 |
| 2025 | 1 | 266 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cascination AG took a median 258 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QQE | Image Management Software For Planning Of Otologic And Neurotologic Procedures | 3 | 3 |
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
| OEW | Tracking, Soft Tissue, Intraoperative | 1 | 1 |
Review panels
Most recent Cascination AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242120 | OTOPLAN | QQE | 2025-04-11 | 266 |
| K232022 | CAS-One IR | JAK | 2024-03-13 | 250 |
| K220300 | OTOPLAN | QQE | 2022-06-24 | 142 |
| K203486 | Otoplan | QQE | 2021-08-20 | 266 |
| K152473 | CAS-One IR | JAK | 2016-01-20 | 142 |
| K143024 | CAS-One Liver | OEW | 2015-04-28 | 189 |
Recalls
openFDA lists no recalls under a recalling firm named Cascination 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 Cascination AG?
FDA lists 6 510(k) clearances under the applicant name “Cascination AG” (first 2015, latest 2025), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cascination AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cascination AG is 220 days. Since 2017: 258 days, versus 128 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cascination AG?
The most frequent FDA product codes under this applicant name are QQE (Image Management Software For Planning Of Otologic And Neurotologic Procedures, 3); JAK (System, X-Ray, Tomography, Computed, 2); OEW (Tracking, Soft Tissue, Intraoperative, 1).
Next steps
- See all 6 Cascination AG clearances with predicates and recalls
- Run predicate analysis for product code QQE, Cascination 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.