FDA applicant
MacroLux Medical Technology Co., Ltd.
FDA records 7 decisions for MacroLux Medical Technology Co., Ltd. (Shenzhen, CN) from 2024 to 2026: 7 510(k) clearances. Most are in product codes FGB (Ureteroscope And Accessories, Flexible/Rigid) and EOQ (Bronchoscope (Flexible Or Rigid)). Since 2016 its 510(k)s took a median of 130 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 6 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 MacroLux Medical 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 2024.
Planning a device like MacroLux Medical 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.
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