510(k) Report

FDA applicant

Shanghai Hua EN Industrial Co, Ltd.

Shanghai, CN2 decisions2022–20220 recalls

FDA records 2 decisions for Shanghai Hua EN Industrial Co, Ltd. (Shanghai, CN) in 2022: 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 Shanghai Hua EN Industrial Co, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2022: 2
2022high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Shanghai Hua EN Industrial Co, Ltd. by year, 2022–2026Sources: 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 1 time; 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.

  • K221222Surgical Face Mask (HNFM0304)Shanghai Hua EN Industrial Co, Ltd. · 20221cites it

What has FDA decided for it lately?

  • K221838Surgical Face Mask (HNFM0103)Shanghai Hua EN Industrial Co, Ltd. · 2022
  • K221222Surgical Face Mask (HNFM0304)Shanghai Hua EN Industrial Co, Ltd. · 2022

All 2 as Shanghai Hua EN Industrial Co, Ltd. →