FDA applicant
Shenzhen Changke Connect Electronics Co., Ltd.
FDA records 8 decisions for Shenzhen Changke Connect Electronics Co., Ltd. (Shenzhen, CN) from 2019 to 2022: 8 510(k) clearances. Most are in product codes DSA (Cable, Transducer And Electrode, Patient…) and DXQ (Blood Pressure Cuff). Since 2016 its 510(k)s took a median of 134 days from receipt to decision, against 149 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 1 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 Changke Connect Electronics Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
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