Monitex Industrial Co., Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Monitex Industrial Co., Ltd.” (first 2005, latest 2017), across 1 product code in 1 review panel. Median 510(k) review time under this name: 207 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 | 377 |
| 2015 | 1 | 207 |
| 2016 | 1 | 249 |
| 2017 | 2 | 560 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Monitex Industrial Co., Ltd. took a median 560 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 145 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | 9 | 9 |
Review panels
- Dental (9)
Most recent Monitex Industrial Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161855 | LED Curing Light | EBZ | 2017-11-27 | 509 |
| K152192 | LED Curing Light | EBZ | 2017-04-07 | 611 |
| K153078 | LED Curing Light GT-2000 | EBZ | 2016-06-28 | 249 |
| K150205 | LED Curing Light | EBZ | 2015-08-24 | 207 |
| K133040 | LED CURING LIGHT | EBZ | 2014-10-07 | 377 |
| K091887 | LED CURING LIGHT, MODEL GT-1500 | EBZ | 2009-09-18 | 86 |
| K080035 | LED CURING LIGHT | EBZ | 2008-03-03 | 56 |
| K060646 | BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 | EBZ | 2006-04-21 | 42 |
| K051203 | BLUELEX | EBZ | 2005-05-25 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Monitex Industrial 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 Monitex Industrial Co., Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Monitex Industrial Co., Ltd.” (first 2005, latest 2017), 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 Monitex Industrial Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Monitex Industrial Co., Ltd. is 207 days.
Which FDA product codes appear under Monitex Industrial Co., Ltd.?
The most frequent FDA product codes under this applicant name are EBZ (Activator, Ultraviolet, For Polymerization, 9).
Next steps
- See all 9 Monitex Industrial Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EBZ, Monitex Industrial 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.