Nemoto Kyorindo Co., Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Nemoto Kyorindo Co., Ltd.” (first 2005, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 138 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 | 1 | 256 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 93 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 29 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nemoto Kyorindo Co., Ltd. took a median 61 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 153 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | 7 | 7 |
| IZQ | Injector, Contrast Medium, Automatic | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Nemoto Kyorindo Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) | DXT | 2024-08-27 | 29 |
| K173450 | PRESS DUO elite, PRESS DUO elite AG | DXT | 2018-02-07 | 93 |
| K133189 | DUAL SHOT ALPHA 7 | DXT | 2014-06-30 | 256 |
| K092896 | REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS | DXT | 2010-10-29 | 403 |
| K091734 | SONIC SHOT GX | IZQ | 2010-05-21 | 344 |
| K071691 | DUAL SHOT ALPHA | DXT | 2007-12-19 | 182 |
| K062168 | CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA | DXT | 2006-08-18 | 18 |
| K052633 | DUAL SHOT - CONTRAST DELIVERY SYSTEM | DXT | 2005-10-17 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Nemoto Kyorindo 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 Nemoto Kyorindo Co., Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Nemoto Kyorindo Co., Ltd.” (first 2005, latest 2024), 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 Nemoto Kyorindo Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nemoto Kyorindo Co., Ltd. is 138 days.
Which FDA product codes appear under Nemoto Kyorindo Co., Ltd.?
The most frequent FDA product codes under this applicant name are DXT (Injector And Syringe, Angiographic, 7); IZQ (Injector, Contrast Medium, Automatic, 1).
Next steps
- See all 8 Nemoto Kyorindo Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXT, Nemoto Kyorindo 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.