Totoku Electric Co., Ltd.: FDA filings under this applicant name
FDA lists 40 510(k) clearances under the applicant name “Totoku Electric Co., Ltd.” (first 2001, latest 2011), across 1 product code in 1 review panel. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 40 | 40 |
Review panels
- Radiology (40)
Most recent Totoku Electric Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113443 | 21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023) | LLZ | 2011-12-23 | 32 |
| K113136 | 21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256) | LLZ | 2011-12-20 | 57 |
| K112145 | MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2 | LLZ | 2011-11-07 | 104 |
| K112604 | 21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356) | LLZ | 2011-10-27 | 50 |
| K111496 | 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR | LLZ | 2011-09-26 | 118 |
| K092728 | 20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A) | LLZ | 2010-11-19 | 441 |
| K090947 | 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A) | LLZ | 2010-08-16 | 500 |
| K081945 | 21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A) | LLZ | 2008-09-12 | 66 |
| K081056 | 21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A) | LLZ | 2008-06-04 | 51 |
| K081055 | 21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A) | LLZ | 2008-06-04 | 51 |
30 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Totoku Electric 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 Totoku Electric Co., Ltd.?
FDA lists 40 510(k) clearances under the applicant name “Totoku Electric Co., Ltd.” (first 2001, latest 2011), across 1 product code 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 Totoku Electric Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Totoku Electric Co., Ltd. is 50 days.
Which FDA product codes appear under Totoku Electric Co., Ltd.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 40).
Next steps
- See all 40 Totoku Electric Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Totoku Electric 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.