Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zhongshan Transtek Electronics Co., Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
346 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123780 | TRANSTEK BLOOD PRESSURE MONITOR | Zhongshan Transtek Electronics Co., Ltd. | 2013-03-01 | 81 | 0 |
| K123781 | TRANSTEK GLASS BODY FAT ANALYZER | Zhongshan Transtek Electronics Co., Ltd. | 2013-01-09 | 30 | 0 |
| K123669 | TRANSTEK WRIST BLOOD PRESSURE MONITOR | Zhongshan Transtek Electronics Co., Ltd. | 2012-12-21 | 22 | 0 |
| K122482 | TRANSTEK WRIST BLOOD PRESSURE MONITOR | Zhongshan Transtek Electronics Co., Ltd. | 2012-10-22 | 69 | 0 |
| K121971 | WITHINGS, SMART BODY SCALE | Zhongshan Transtek Electronics Co., Ltd. | 2012-09-27 | 84 | 0 |
| K120058 | TRANSTEK BLOOD PRESSURE MONITOR | Zhongshan Transtek Electronics Co., Ltd. | 2012-01-31 | 22 | 0 |
| K112932 | TRANSTEK | Zhongshan Transtek Electronics Co., Ltd. | 2011-11-01 | 29 | 0 |
| K101681 | TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB- | Zhongshan Transtek Electronics Co., Ltd. | 2011-05-27 | 346 | 0 |
| K102191 | TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; | Zhongshan Transtek Electronics Co., Ltd. | 2011-05-02 | 272 | 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