Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Guangdong Transtek Medical Electronics Co., Ltd. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
238 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | Guangdong Transtek Medical Electronics Co., Ltd. | 2025-01-30 | 125 | 0 |
| K241351 | Blood Pressure Monitor (TMB-2092-G) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-08-21 | 100 | 0 |
| K240832 | Blood Pressure Monitor (BBZ32-AA01) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-06-07 | 73 | 0 |
| K240254 | Blood Pressure Monitor (TMB-2296-BT) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-05-31 | 121 | 0 |
| K240102 | Blood Pressure Monitor (TMB-2287-B) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-04-29 | 104 | 0 |
| K233130 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-12-20 | 84 | 0 |
| K232713 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-11-28 | 84 | 0 |
| K232621 | Blood pressure monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-11-22 | 85 | 0 |
| K223374 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-06-30 | 238 | 0 |
| K220676 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2022-08-29 | 174 | 0 |
| K202891 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2021-03-09 | 162 | 0 |
| K202599 | Transtek Wrist Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2020-12-06 | 89 | 0 |
| K181832 | Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital | Guangdong Transtek Medical Electronics Co., Ltd. | 2019-04-09 | 274 | 0 |
| K161886 | Transtek Blood Pressure Monitor, Welch Allyn Remote Monitori | Guangdong Transtek Medical Electronics Co., Ltd. | 2016-10-14 | 95 | 0 |
| K131394 | TRANSTEK GLASS BODY FAT ANALYZER | Guangdong Transtek Medical Electronics Co., Ltd. | 2013-09-18 | 126 | 0 |
| K131395 | TRANSTEK BLOOD PRESSURE MONITOR | Guangdong Transtek Medical Electronics Co., Ltd. | 2013-06-19 | 35 | 0 |
| K130311 | TRANSTEK BODY FAT ANALYZER | Guangdong Transtek Medical Electronics Co., Ltd. | 2013-05-30 | 111 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda