510(k) Report

FDA applicant

Shenzhen Yuanxing Nano-Pharma Co., Ltd.

Shenzhen, CN1 decision2016–20160 recalls

FDA records 1 decision for Shenzhen Yuanxing Nano-Pharma Co., Ltd. (Shenzhen, CN) in 2016: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). 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

How often FDA has decided Shenzhen Yuanxing Nano-Pharma Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Shenzhen Yuanxing Nano-Pharma Co., Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K152544Agem Ag Mesh Dressing with SilverShenzhen Yuanxing Nano-Pharma Co., Ltd. · 2016

The one decision as Shenzhen Yuanxing Nano-Pharma Co., Ltd. →