FDA applicant
Qingdao Hisense Medical Equipment Co., Ltd.
FDA records 9 decisions for Qingdao Hisense Medical Equipment Co., Ltd. (Qingdao, CN) from 2015 to 2024: 9 510(k) clearances. Most are in product codes PGY (Display, Diagnostic Radiology) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 115 days from receipt to decision, against 60 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 2 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 Qingdao Hisense Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
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