FDA applicant
Shenzhen Creative Industry Co., Ltd.
FDA records 11 decisions for Shenzhen Creative Industry Co., Ltd. (Shenzhen, CN) from 2007 to 2021: 11 510(k) clearances. Most are in product codes DQA (Oximeter) and MWI (Monitor, Physiological, Patient (Without…). Since 2016 its 510(k)s took a median of 242 days from receipt to decision, against 190 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 8 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 Creative Industry Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
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