FDA applicant
Shenzhen Medke Technology Co., Ltd.
FDA records 3 decisions for Shenzhen Medke Technology Co., Ltd. (Shenzhen, CN) from 2016 to 2025: 3 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and DXQ (Blood Pressure Cuff). Its devices cite 3 predicates, 0 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 Shenzhen Medke Technology 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 2016.
Planning a device like Shenzhen Medke Technology Co., Ltd.’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