Ashitaka Factory of Terumo Corporation: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ashitaka Factory of Terumo Corporation” (first 2013, latest 2021), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 112 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Terumo, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 13 |
| 2014 | 0 | — |
| 2015 | 2 | 156 |
| 2016 | 1 | 133 |
| 2017 | 1 | 177 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 92 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ashitaka Factory of Terumo Corporation took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Ashitaka Factory of Terumo Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203521 | FineCross M3 | DQY | 2021-03-03 | 92 |
| K170223 | Progreat | DQO | 2017-07-21 | 177 |
| K161546 | R2P SlenGuide | DQY | 2016-10-14 | 133 |
| K152740 | Radifocus Glidewire | DQX | 2015-11-16 | 54 |
| K150232 | Radifocus Optitorque Angiographic Catheter | DQO | 2015-10-19 | 259 |
| K130520 | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR | DTZ | 2013-03-13 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Ashitaka Factory of Terumo Corporation.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ashitaka Factory of Terumo Coporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ashitaka Factory of Terumo Corporation?
FDA lists 6 510(k) clearances under the applicant name “Ashitaka Factory of Terumo Corporation” (first 2013, latest 2021), 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 Ashitaka Factory of Terumo Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ashitaka Factory of Terumo Corporation is 112 days.
Which FDA product codes appear under Ashitaka Factory of Terumo Corporation?
The most frequent FDA product codes under this applicant name are DQO (Catheter, Intravascular, Diagnostic, 2); DQY (Catheter, Percutaneous, 2); DQX (Wire, Guide, Catheter, 1).
Next steps
- See all 6 Ashitaka Factory of Terumo Corporation clearances with predicates and recalls
- Run predicate analysis for product code DQO, Ashitaka Factory of Terumo Corporation'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.