510(k) Report

FDA applicant

Zhuhai DR Medical Instruments Co., Ltd.

Zhuhai, CN2 decisions2021–20260 recalls

FDA records 2 decisions for Zhuhai DR Medical Instruments Co., Ltd. (Zhuhai, CN) from 2021 to 2026: 2 510(k) clearances. Most are in product codes DXT (Injector And Syringe, Angiographic) and MEG (Syringe, Antistick). Its devices cite 3 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2021

2021: 12026 (partial year): 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Zhuhai DR Medical Instruments Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXTInjector And Syringe, Angiographic1decision
  • MEGSyringe, Antistick1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K251788Extension tubeZhuhai DR Medical Instruments Co., Ltd. · 2026
  • K212226DR Safety Syringe, Sterile Hypodermic needle for Single useZhuhai DR Medical Instruments Co., Ltd. · 2021

All 2 as Zhuhai DR Medical Instruments Co., Ltd. →