Takeda Medical, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Takeda Medical, Inc.” (first 1985, latest 1986), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 154 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 8 | 8 |
| FLL | Continuous Measurement Thermometer | 3 | 3 |
Review panels
- Cardiovascular (8)
- General Hospital (3)
Most recent Takeda Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K854797 | TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-731 | DXN | 1986-05-09 | 158 |
| K853158 | DIGITAL SPHYGMOMANOMETER MODEL 7620 | DXN | 1985-11-14 | 107 |
| K851223 | COPAL DIGITAL SPHYGMOMANOMETER UA-560 | DXN | 1985-09-09 | 167 |
| K852564 | COPAL UA-512 DIGITAL BLOOD PRESSURE MONITOR | DXN | 1985-08-19 | 91 |
| K843390 | COPAL DIGITAL SPHYGMOMANOMETER UA-535 | DXN | 1985-05-15 | 259 |
| K844285 | COPAL DIGITAL SPHYGMOMAMOMETER UA-550 | DXN | 1985-04-18 | 164 |
| K842388 | COPAL DIGITAL SPHYGMOMANOMETER UA-510 | DXN | 1985-02-13 | 240 |
| K844284 | COPAL DIGITAL SPHYGMOMANOMETER UA-540 | DXN | 1985-02-08 | 95 |
| K850196 | COPAL DIGITAL THERMOMETER UF-22B | FLL | 1985-02-07 | 20 |
| K850195 | COPAL DIGITAL THERMOMETER UF-12 | FLL | 1985-02-07 | 20 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Takeda Medical, Inc..
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.
- Takeda Pharmaceuticals (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Takeda Medical, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Takeda Medical, Inc.” (first 1985, latest 1986), across 2 product codes in 2 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 Takeda Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Takeda Medical, Inc. is 154 days.
Which FDA product codes appear under Takeda Medical, Inc.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 8); FLL (Continuous Measurement Thermometer, 3).
Next steps
- See all 11 Takeda Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Takeda Medical, Inc.'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.