510(k) Report

FDA applicant

Zhende Medical Co., Ltd.

Shaoxing, CN2 decisions2020–20210 recalls

FDA records 2 decisions for Zhende Medical Co., Ltd. (Shaoxing, CN) from 2020 to 2021: 2 510(k) clearances. All are in product code FXX (Mask, Surgical). Its devices cite 2 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, last Nov 3, 2026

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

How often FDA has decided Zhende Medical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020: 12021: 1
2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Zhende Medical Co., Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FXXMask, Surgical2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 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.

  • K201729Medical MaskZhende Medical Co., Ltd. · 20203cite it

What has FDA decided for it lately?

  • K210020Medical MaskZhende Medical Co., Ltd. · 2021
  • K201729Medical MaskZhende Medical Co., Ltd. · 2020

All 2 as Zhende Medical Co., Ltd. →