510(k) Report

FDA applicant

Wenzhou Wuzhou Group Co., Ltd.

Los Angeles, CA1 decision2006–20060 recalls

FDA records 1 decision for Wenzhou Wuzhou Group Co., Ltd. (Los Angeles, CA) in 2006: 1 510(k) clearance. All are in product code FMF (Syringe, Piston). 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, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Wenzhou Wuzhou Group Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wenzhou Wuzhou Group Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wenzhou Wuzhou Group Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wenzhou Wuzhou Group 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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Which product codes does it file in?

  • FMFSyringe, Piston1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060211Wuzhou Syringe, with/Without NeedleWenzhou Wuzhou Group Co., Ltd. · 20063cite it

What has FDA decided for it lately?

  • K060211Wuzhou Syringe, with/Without NeedleWenzhou Wuzhou Group Co., Ltd. · 2006

The one decision as Wenzhou Wuzhou Group Co., Ltd. →