Guangdong Transtek Medical Electronics Co., Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Guangdong Transtek Medical Electronics Co., Ltd.” (first 2013, latest 2025), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 104 days. Since 2017 the median was 104 days, against 174 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2013 | 3 | 111 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 95 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 274 |
| 2020 | 1 | 89 |
| 2021 | 1 | 162 |
| 2022 | 1 | 174 |
| 2023 | 4 | 84 |
| 2024 | 4 | 102 |
| 2025 | 1 | 125 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Guangdong Transtek Medical Electronics Co., Ltd. took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 174 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 14 | 14 |
| MNW | Analyzer, Body Composition | 2 | 2 |
| NBW | System, Test, Blood Glucose, Over The Counter | 1 | 1 |
Review panels
Most recent Guangdong Transtek Medical Electronics Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | NBW | 2025-01-30 | 125 |
| K241351 | Blood Pressure Monitor (TMB-2092-G) | DXN | 2024-08-21 | 100 |
| K240832 | Blood Pressure Monitor (BBZ32-AA01) | DXN | 2024-06-07 | 73 |
| K240254 | Blood Pressure Monitor (TMB-2296-BT) | DXN | 2024-05-31 | 121 |
| K240102 | Blood Pressure Monitor (TMB-2287-B) | DXN | 2024-04-29 | 104 |
| K233130 | Blood Pressure Monitor | DXN | 2023-12-20 | 84 |
| K232713 | Blood Pressure Monitor | DXN | 2023-11-28 | 84 |
| K232621 | Blood pressure monitor | DXN | 2023-11-22 | 85 |
| K223374 | Blood Pressure Monitor | DXN | 2023-06-30 | 238 |
| K220676 | Blood Pressure Monitor | DXN | 2022-08-29 | 174 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Guangdong Transtek Medical 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.
- Guangdong Biolight Meditech Co., Ltd. (21 510(k)s)
- Guangdong Kingfa Sci. & Tech.Co., Ltd. (14 510(k)s)
- Guangdong Optomedic Technologies, Inc. (9 510(k)s)
- Guangdong Horigen Mother & Baby Products Co., Ltd. (7 510(k)s)
- Guangdong Genial Technology Co., Ltd. (5 510(k)s)
- Guangdong Newdermo Biotech Co., Ltd. (5 510(k)s)
- Guangdong Jinme Medical Technology Co., Ltd. (4 510(k)s)
- Guangdong Prestige Technology Co., Ltd. (4 510(k)s)
- Guangdong Youmeng Electrical Technology Co., Ltd. (4 510(k)s)
- Guangdong Gymda Medical Technology Co.,Ltd (2 510(k)s)
- Guangdong Kaiyang Medical Technology Co., Ltd. (2 510(k)s)
- Guangdong Xinyu Electronic and Technology Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Guangdong Transtek Medical Electronics Co., Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Guangdong Transtek Medical Electronics Co., Ltd.” (first 2013, latest 2025), across 3 product codes in 3 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 Guangdong Transtek Medical Electronics Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guangdong Transtek Medical Electronics Co., Ltd. is 104 days. Since 2017: 104 days, versus 174 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Guangdong Transtek Medical Electronics Co., Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 14); MNW (Analyzer, Body Composition, 2); NBW (System, Test, Blood Glucose, Over The Counter, 1).
Next steps
- See all 17 Guangdong Transtek Medical Electronics Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Guangdong Transtek Medical 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.