Zhongshan Transtek Electronics Co., Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Zhongshan Transtek Electronics Co., Ltd.” (first 2011, latest 2013), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 69 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 | 4 | 46 |
| 2013 | 2 | 56 |
| 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 5 | 5 |
| MNW | Analyzer, Body Composition | 4 | 4 |
Review panels
Most recent Zhongshan Transtek Electronics Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123780 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | 2013-03-01 | 81 |
| K123781 | TRANSTEK GLASS BODY FAT ANALYZER | MNW | 2013-01-09 | 30 |
| K123669 | TRANSTEK WRIST BLOOD PRESSURE MONITOR | DXN | 2012-12-21 | 22 |
| K122482 | TRANSTEK WRIST BLOOD PRESSURE MONITOR | DXN | 2012-10-22 | 69 |
| K121971 | WITHINGS, SMART BODY SCALE | MNW | 2012-09-27 | 84 |
| K120058 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | 2012-01-31 | 22 |
| K112932 | TRANSTEK | MNW | 2011-11-01 | 29 |
| K101681 | TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 | DXN | 2011-05-27 | 346 |
| K102191 | TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER | MNW | 2011-05-02 | 272 |
Recalls
openFDA lists no recalls under a recalling firm named Zhongshan Transtek Electronics 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.
- Zhongshan A&J Medical Equipment Co., Ltd. (4 510(k)s)
- Zhongshan Bisen Plastic Electronic Products Co., Ltd. (2 510(k)s)
- Zhongshan Huibao Weighing Apparatus Co., Ltd. (1 510(k)s)
- Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. (1 510(k)s)
- Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. (1 510(k)s)
- Zhongshan Qizhe Technology Co., Ltd. (1 510(k)s)
- Zhongshan Saifute Labor Protective Articles Co., Ltd. (1 510(k)s)
- Zhongshan Sulenz Intelligent Technology Co., Ltd. (1 510(k)s)
- Zhongshan Xiaolan Town Senlan Electronic Factory (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zhongshan Transtek Electronics Co., Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Zhongshan Transtek Electronics Co., Ltd.” (first 2011, latest 2013), across 2 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 Zhongshan Transtek Electronics Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zhongshan Transtek Electronics Co., Ltd. is 69 days.
Which FDA product codes appear under Zhongshan Transtek Electronics Co., Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 5); MNW (Analyzer, Body Composition, 4).
Next steps
- See all 9 Zhongshan Transtek Electronics Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Zhongshan Transtek Electronics 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.