FDA applicant
Well Lead Medical Co., Ltd.
FDA records 17 decisions for Well Lead Medical Co., Ltd. (Guangzhou, CN) from 2009 to 2025: 17 510(k) clearances. Most are in product codes EZL (Catheter, Retention Type, Balloon) and FED (Endoscopic Access Overtube…). Since 2016 its 510(k)s took a median of 256 days from receipt to decision, against 126 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 6 of them its own earlier devices. 2 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Well Lead Medical 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
1in 2024
Class I Class II/III not classified
Planning a device like Well Lead Medical Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Well”
FDA records each applicant name separately; these may or may not be the same firm.