510(k) Report

FDA applicant

Wealth Lead Industrial Limited

Hong Kong, CN1 decision2022–20220 recalls

FDA records 1 decision for Wealth Lead Industrial Limited (Hong Kong, CN) in 2022: 1 510(k) clearance. All are in product code FXX (Mask, Surgical). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Wealth Lead Industrial Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Wealth Lead Industrial Limited by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wealth Lead Industrial Limited’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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Other applicant names beginning “Wealth”

FDA records each applicant name separately; these may or may not be the same firm.