FDA applicant
Zylox Medtech Co., Ltd.
FDA records 2 decisions for Zylox Medtech Co., Ltd. (Hangzhou, CN) in 2026: 2 510(k) clearances. Most are in product codes LIT (Catheter, Angioplasty, Peripheral, Transluminal) and PNO (Catheter, Percutaneous, Cutting/Scoring). Its devices cite 1 predicate, 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 Zylox Medtech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
Planning a device like Zylox Medtech 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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