Alpinion Medical Systems Co., Ltd.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Alpinion Medical Systems Co., Ltd.” (first 2011, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 97 days. Since 2017 the median was 126 days, against 101 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 | 5 | 30 |
| 2013 | 2 | 82 |
| 2014 | 2 | 30 |
| 2015 | 1 | 121 |
| 2016 | 2 | 106 |
| 2017 | 1 | 94 |
| 2018 | 3 | 114 |
| 2019 | 1 | 126 |
| 2020 | 2 | 137 |
| 2021 | 2 | 103 |
| 2022 | 3 | 184 |
| 2023 | 1 | 139 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Alpinion Medical Systems Co., Ltd. took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 25 | 25 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
- Radiology (26)
Most recent Alpinion Medical Systems Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223564 | X-CUBE 50, X-CUBE 60 | IYN | 2023-04-17 | 139 |
| K221093 | X-CUBE 70, X-CUBE 90 | IYN | 2022-10-14 | 184 |
| K220857 | X-CUBE 50, X-CUBE 60 | IYN | 2022-10-13 | 204 |
| K213523 | X-CUBE i8, X-CUBE i9 | IYN | 2022-01-28 | 86 |
| K211300 | X-CUBE 90 | IYN | 2021-08-09 | 103 |
| K211299 | X-CUBE 70 | IYN | 2021-08-09 | 103 |
| K200450 | X-Cube 70 | IYN | 2020-07-10 | 137 |
| K200449 | X-Cube 90 | IYN | 2020-07-10 | 137 |
| K182594 | E-CUBE i7 | IYN | 2019-01-24 | 126 |
| K182845 | minisono | IYN | 2018-12-27 | 79 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Alpinion Medical Systems Co., Ltd..
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 Alpinion Medical Systems Co., Ltd.?
FDA lists 26 510(k) clearances under the applicant name “Alpinion Medical Systems Co., Ltd.” (first 2011, latest 2023), across 2 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 Alpinion Medical Systems Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alpinion Medical Systems Co., Ltd. is 97 days. Since 2017: 126 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Alpinion Medical Systems Co., Ltd.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 25); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1).
Next steps
- See all 26 Alpinion Medical Systems Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Alpinion Medical Systems Co., Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.