Otsuka Pharmaceutical Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Otsuka Pharmaceutical Co., Ltd.” (first 1999, latest 2010), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 129 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 2 |
| MSQ | Test, Urea (Breath Or Blood) | 2 | 2 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
| LYR | Helicobacter Pylori | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- Microbiology (3)
Most recent Otsuka Pharmaceutical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092817 | POC-AS10 AUTO SAMPLER | MSQ | 2010-03-09 | 176 |
| K052716 | RAPIRUN H. PYLORI ANTIBODY DETECTION KIT | LYR | 2006-11-16 | 413 |
| K041148 | POCONE INFRARED SPECTROPHOTOMETER | MSQ | 2004-07-15 | 73 |
| K013371 | UBIT-IR300 INFRARED SPECTROMETRY SYSTEM | JJQ | 2001-12-21 | 71 |
| K001032 | RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY | CHH | 2000-07-24 | 116 |
| K991083 | RLP CHOLESTEROL IMMUNOSEPARATION ASSAY | CHH | 1999-08-20 | 142 |
Recalls
openFDA lists no recalls under a recalling firm named Otsuka Pharmaceutical 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.
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.
- Otsuka America Pharmaceutical, Inc. (3 510(k)s)
- Otsuka Electronics (2 510(k)s)
- Otsuka Electronics USA, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Otsuka Pharmaceutical Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Otsuka Pharmaceutical Co., Ltd.” (first 1999, latest 2010), across 4 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 Otsuka Pharmaceutical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Otsuka Pharmaceutical Co., Ltd. is 129 days.
Which FDA product codes appear under Otsuka Pharmaceutical Co., Ltd.?
The most frequent FDA product codes under this applicant name are CHH (Enzymatic Esterase--Oxidase, Cholesterol, 2); MSQ (Test, Urea (Breath Or Blood), 2); JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 1).
Next steps
- See all 6 Otsuka Pharmaceutical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CHH, Otsuka Pharmaceutical 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, 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.