Tanabe U.S.A., Inc.: FDA clearances and approvals
Tanabe U.S.A., Inc. has 8 FDA 510(k) clearances (first 1993, latest 1994), across 1 product code in 1 review panel. Median 510(k) review time: 211 days.
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 |
|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 8 | 8 |
Review panels
Most recent Tanabe U.S.A., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932368 | UROPAPER EIKEN 6B | JIL | 1994-01-13 | 269 |
| K932366 | UROPAPER EIKEN HAG | JIL | 1993-11-26 | 221 |
| K932365 | UROPAPER EIKEN AG | JIL | 1993-11-26 | 221 |
| K932369 | UROPAPER EIKEN 7 | JIL | 1993-11-16 | 211 |
| K932367 | UROPAPER EIKEN 8 | JIL | 1993-11-16 | 211 |
| K932364 | UROPAPER EIKEN GP | JIL | 1993-11-16 | 211 |
| K932363 | UROPAPER EIKEN GK | JIL | 1993-11-16 | 211 |
| K931897 | UROPAPER | JIL | 1993-11-16 | 211 |
Recalls
openFDA lists no recalls under a recalling firm named Tanabe U.S.A., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Tanabe U.S.A., Inc. have?
Tanabe U.S.A., Inc. has 8 FDA 510(k) clearances (first 1993, latest 1994), across 1 product code in 1 review panel.
How long does FDA take to clear Tanabe U.S.A., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tanabe U.S.A., Inc.'s cleared 510(k)s is 211 days.
What devices does Tanabe U.S.A., Inc. make?
Its most frequent FDA product codes are JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative), 8).
Has Tanabe U.S.A., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tanabe U.S.A., Inc. Related entities may recall under other names.
Next steps
- See all 8 Tanabe U.S.A., Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIL, Tanabe U.S.A., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.