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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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.2025-01-301250
K241351Blood Pressure Monitor (TMB-2092-G)Guangdong Transtek Medical Electronics Co., Ltd.2024-08-211000
K240832Blood Pressure Monitor (BBZ32-AA01)Guangdong Transtek Medical Electronics Co., Ltd.2024-06-07730
K240254Blood Pressure Monitor (TMB-2296-BT)Guangdong Transtek Medical Electronics Co., Ltd.2024-05-311210
K240102Blood Pressure Monitor (TMB-2287-B)Guangdong Transtek Medical Electronics Co., Ltd.2024-04-291040
K233130Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd.2023-12-20840
K232713Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd.2023-11-28840
K232621Blood pressure monitorGuangdong Transtek Medical Electronics Co., Ltd.2023-11-22850
K223374Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd.2023-06-302380
K220676Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd.2022-08-291740
K202891Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd.2021-03-091620
K202599Transtek Wrist Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd.2020-12-06890
K181832Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Guangdong Transtek Medical Electronics Co., Ltd.2019-04-092740
K161886Transtek Blood Pressure Monitor, Welch Allyn Remote MonitoriGuangdong Transtek Medical Electronics Co., Ltd.2016-10-14950
K131394TRANSTEK GLASS BODY FAT ANALYZERGuangdong Transtek Medical Electronics Co., Ltd.2013-09-181260
K131395TRANSTEK BLOOD PRESSURE MONITORGuangdong Transtek Medical Electronics Co., Ltd.2013-06-19350
K130311TRANSTEK BODY FAT ANALYZERGuangdong Transtek Medical Electronics Co., Ltd.2013-05-301110

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