FDA applicant
Guangdong Transtek Medical Electronics Co., Ltd.
FDA records 17 decisions for Guangdong Transtek Medical Electronics Co., Ltd. (Zhongshan, CN) from 2013 to 2025: 17 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and MNW (Analyzer, Body Composition). Since 2016 its 510(k)s took a median of 100 days from receipt to decision, against 156 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 9 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Guangdong Transtek Medical Electronics Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Guangdong Transtek Medical Electronics…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report